Clinical Research Directory

Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy

Pain after laparoscopic cholecystectomy remains clinically relevant, and current recommendations favour multimodal, opioid-sparing analgesia including regional techniques. The recto-intercostal fascial plane block (RIFPB) is a recently described technique in which local anesthetic is injected into the plane between the rectus abdominis muscle and the 6th and 7th costal cartilages, targeting the anterior and lateral cutaneous branches of the sixth to ninth thoracic (T6-T9) thoracoabdominal nerves. In the investigators' previous randomized controlled trial, bilateral RIFPB after laparoscopic cholecystectomy significantly reduced the need for rescue analgesia (17.9% versus 55.3%) and pain scores during the first 12 postoperative hours. That trial used 30 mL of 0.25% bupivacaine per side (60 mL, 150 mg in total), a dose approaching the recommended upper limit, and whether lower doses provide comparable analgesia remains unknown. Because fascial plane blocks depend on local anesthetic spread, large volumes are preferred, increasing the total dose and the risk of local anesthetic systemic toxicity (LAST); lowering the concentration as volume increases has therefore been recommended. Equal-volume studies of transversus abdominis plane and erector spinae plane blocks suggest that lower concentrations provide comparable analgesia, but no study has compared concentrations for RIFPB. This trial will compare, at a fixed volume of 25 mL per side (50 mL in total), bilateral RIFPB with 0.25% bupivacaine (125 mg), bilateral RIFPB with 0.125% bupivacaine (62.5 mg), and routine port-site infiltration with 25 mL of 0.25% bupivacaine without a block (control) in adults undergoing elective laparoscopic cholecystectomy under general anesthesia. Ninety patients will be randomly allocated in a 1:1:1 ratio. The primary outcome is total rescue tramadol consumption during the first 24 postoperative hours. Secondary outcomes include numeric rating scale (NRS) pain scores at rest and on movement (coughing), the need for and time to first rescue analgesia, nausea, vomiting and pruritus, block-related complications and signs of LAST, patient satisfaction, and length of hospital stay. The investigators hypothesize that RIFPB at either concentration will reduce rescue tramadol consumption and pain scores compared with control, and that the lower concentration will halve the total bupivacaine dose (62.5 mg instead of 125 mg), thereby reducing the risk of LAST.

Hasson Versus Veress Access With Umbilical Versus Epigastric Gallbladder Extraction in Laparoscopic Cholecystectomy

This single-centre randomised pilot study compared two strategies for primary abdominal access and gallbladder extraction in elective laparoscopic cholecystectomy: open (Hasson) umbilical access with extraction of the gallbladder through the umbilical incision, and closed (Veress needle) access with extraction through the epigastric port. Access time, gallbladder extraction time, total operative time and postoperative pain were compared. Enrolment was stopped in March 2020 when elective laparoscopic surgery was suspended because of the COVID-19 pandemic. This trial was registered retrospectively

Timing of CHolecystectomy In Severe PAncreatitis

The goal of this clinical trial is to compare outcomes for interval or early laparoscopic cholecystectomy in patients with moderately severe and severe pancreatitis. The main question\[s\] it aims to answer are: * To establish whether there is a difference in surgical outcomes comparing patients diagnosed with severe or moderately severe pancreatitis on which early cholecystectomy was performed versus performing interval cholecystectomy. * The primary endpoint will be to evaluate major complications, defined as a Clavien-Dindo score greater than or equal to III/V. * Secondary endpoints include evaluating minor complications (defined as a Clavien-Dindo score below III/V), biliary disease recurrence, mortality, postoperative hospital stay and postoperative admittance into an intensive care unit. Participants will be randomly assigned to either group: early cholecystectomy during the pancreatitis hospitalization or interval cholecystectomy scheduled 4 weeks after clinical resolution of pancreatitis.

Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy

This prospective observational study will examine how electrosurgical activation patterns during elective laparoscopic cholecystectomy are associated with surgeon experience and intraoperative difficulty. Adult patients scheduled for elective laparoscopic cholecystectomy at University Hospital of Split will receive standard clinical care; the study does not assign an intervention or change the surgical technique. A fixed camera will record only the laparoscopic monitor, and a directional microphone will record the audible signals of the electrosurgical generator. The study includes a cross-sectional comparison among surgeons with different cumulative experience and a longitudinal assessment of developing surgeons as they gain additional experience. Activation patterns will be analyzed separately during dissection of the hepatocystic triangle and separation of the gallbladder from the liver bed. Intraoperative difficulty will be graded from the initial operative video using the Parkland Grading Scale by two independent assessors, with adjudication when needed.

USG-Guided TAPA vs RIFB Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy (LC) can cause moderate-to-severe postoperative pain from visceral, referred shoulder, and incisional sources. Multimodal analgesia is recommended, but opioids carry significant side effects. Ultrasound-guided interfascial plane blocks offer a safe alternative. The Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) blocks T5-T12 dermatomes, while the Recto-Intercostal Fascial Plane Block (RIFPB) provides sensory blockade across the upper anterolateral abdomen. This study compares the postoperative analgesic efficacy of bilateral M-TAPA versus bilateral RIFPB in patients undergoing LC.

Time to Loss of Consciousness With Remimazolam Versus Propofol for Anesthetic Induction in Laparoscopic Cholecystectomy

The goal of this clinical trial is to compare two medicines used to induce general anesthesia in adults undergoing elective laparoscopic cholecystectomy. The study aims to determine whether remimazolam leads to a different time to loss of consciousness than propofol. The main question it aims to answer is: Does remimazolam change the time to loss of consciousness compared with propofol during anesthesia induction? Researchers will compare remimazolam with propofol to evaluate the time required for participants to lose consciousness. The study will also compare blood pressure, heart rate, and other safety outcomes during anesthesia induction. Participants will: * Be randomly assigned to receive either remimazolam or propofol for anesthesia induction. * Receive standard monitoring and anesthesia care throughout surgery. * Have their time to loss of consciousness, vital signs, and any adverse events recorded during the induction period.

A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy

This study is designed to compare three sedative medications used during general anesthesia for gallbladder removal surgery (laparoscopic cholecystectomy) and their effects on nausea and vomiting after surgery. Background Nausea and vomiting after surgery (postoperative nausea and vomiting, PONV) is a common problem, affecting up to 75% of patients undergoing gallbladder surgery. It can cause discomfort, delay recovery, and lead to other complications. Three medications are commonly used to start and maintain anesthesia: propofol, ciprofol, and remimazolam. This study aims to find out which one is associated with the least nausea and vomiting. Study Design This is a prospective, randomized, controlled, single-blind clinical trial. A total of 114 adult patients scheduled for elective laparoscopic cholecystectomy at Xi'an Aerospace Hospital will be randomly assigned to one of three groups (38 patients each): Propofol group Ciprofol group Remimazolam group All patients will receive the same anti-nausea prevention and pain control after surgery, regardless of their group. Primary Outcome (Main Measure) The percentage of patients who experience any nausea and/or vomiting within the first 24 hours after surgery. Secondary Outcomes (Other Measures) Percentage of patients who experience vomiting within 24 hours after surgery Percentage of patients who experience nausea within 24 hours after surgery Number of nausea, vomiting, and combined PONV episodes within 24 hours Pain level measured on a 0-10 visual analog scale (VAS) at 0, 6, 12, and 24 hours after surgery (0 = no pain, 10 = worst pain imaginable) Highest pain score reported within the first 24 hours after surgery Significance The results will help doctors choose the best sedative medication to reduce nausea and vomiting after gallbladder surgery, especially for patients who are at higher risk, such as women.

Effects of Postoperative Video-assisted Early Mobilization on Recovery Outcomes

This randomized controlled trial aims to evaluate the effects of video-assisted early mobilization education on postoperative recovery in patients undergoing laparoscopic cholecystectomy. As part of the intervention, structured and professionally produced educational videos will be used to explain the physiological benefits of early mobilization in the preoperative period and to demonstrate step-by-step mobilization techniques in the postoperative period. Patients in the intervention group will receive video-assisted mobilization education in addition to standard postoperative care, while patients in the control group will receive standard care alone. Physical activity levels will be objectively monitored using wearable activity tracking devices during the first 24 hours after surgery. The study will assess the effects of video-assisted early mobilization education on postoperative physiological stress response, pain, nausea and vomiting, blood glucose levels, mobilization performance, gastrointestinal recovery, length of hospital stay, and patient satisfaction. In addition, postoperative complications, emergency department visits, and hospital readmissions within 30-days after surgery will be evaluated as exploratory outcomes.

Effect of Labetalol, Magnesium Sulfate, or Lidocaine on Opioid Consumption During Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy (gallbladder removal) is one of the most common abdominal operations performed worldwide. Despite its minimally invasive approach, up to half of patients experience notable postoperative pain, which often requires opioid painkillers. Reducing perioperative opioid consumption through non-opioid medications helps minimize opioid-related side effects, improve comfort, and enhance postoperative recovery. The primary purpose of this clinical trial is to compare the pain-relieving and opioid-sparing effects of three intravenous medications (labetalol, magnesium sulfate, and lidocaine) administered during elective laparoscopic cholecystectomy under general anesthesia. Adult participants aged 18 to 60 years will be randomly assigned to one of three parallel groups: * Group Lb: Receives intravenous labetalol as an initial loading infusion before induction followed by a continuous infusion during surgery. * Group M: Receives intravenous magnesium sulfate as an initial loading infusion before induction followed by a continuous infusion during surgery. * Group L: Receives intravenous lidocaine as an initial loading infusion before induction followed by a continuous infusion during surgery. The main outcome measured is total perioperative opioid consumption during surgery and throughout the first 24 postoperative hours. Investigators will also assess hemodynamic parameters (heart rate and blood pressure), blood oxygen levels, postoperative pain intensity scores, surgeon satisfaction, and the occurrence of any adverse effects.

STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC. There are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block. We hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big. The aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.

Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used for the diagnosis and treatment of pancreatobiliary diseases. While Monitored Anesthesia Care (MAC) enhances the efficiency of ERCP, deep sedation introduces significant airway risks, particularly hypoxemia resulting from sedative-induced upper airway collapse. With reported hypoxemia rates ranging from 10% to 69%, and the potential for severe complications such as myocardial ischemia and neurological damage, effective airway management is paramount. Supraglottic oxygenation via oral transtracheal catheter provides a viable method for relieving obstruction and enabling positive pressure ventilation, serving as a less invasive alternative to tracheal intubation. Despite its proven utility in other settings, this technique has not yet been evaluated in the context of deeply sedated ERCP.

Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis

A prospective, interventional, single arm study to investigate clinical feasibility of single-stage cholecystectomy and common bile duct exploration using da Vinci SP Surgical System (robotic surgery)

Improvised Endobag vs Direct Gallbladder Extraction in Laparoscopic Cholecystectomy

Eligigble patients will be enrolled after obtaining informed consent. Basic information such as age, gender, body weight, smoking and alcohol history, number of gallstones, and gallbladder characteristics will be recorded. During surgery, the method used to remove the gallbladder, the port used for extraction, and the duration of surgery will be documented. Any gallbladder perforation, leakage of bile, or spillage of gallstones during the procedure will also be recorded. After surgery, patients will be monitored in the hospital for 24 hours. Their pain will be assessed before discharge. Patients will then be followed in the outpatient clinic for 10 days to assess wound healing and identify any wound infection or other complications. The study aims to compare the safety and effectiveness of an improvised retrieval bag with removal of the gallbladder without a retrieval bag during laparoscopic surgery.

ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly

The goal of this study is to compare safety and efficacy of laparoscopic cholecystectomy versus wait-and-see policy after endoscopic removal of common bile duct stones in elderly. The primary endpoint is a composite outcome: Death or major postoperative complications or recurrent biliary disease within 1 year after randomization.

Rectointercostal Plane Block (RICPB) for Laparoscopic Cholecystectomy

This prospective randomized controlled trial is designed to evaluate the analgesic efficacy of ultrasound-guided rectointercostal plane block (RICPB) in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized to receive unilateral right-sided RICPB at the end of surgery. Postoperative opioid consumption, Numeric Rating Scale (NRS) pain scores, and postoperative complications will be assessed to determine the effectiveness of RICPB in postoperative pain management.

EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study

Cholecystectomy is considered the standard definitive treatment after an acute biliary event (biliary colic, acute pancreatitis, cholangitis, or choledocholithiasis). However, in elderly patients and/or those with significant comorbidities, surgery is often not feasible, leaving this population at high risk of biliary event recurrence (approximately 25-31% per year without treatment). EUS-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS) is an established endoscopic technique currently recommended for acute cholecystitis in patients unfit for surgery. It creates an internal fistula between the gallbladder and the adjacent digestive tract, allowing direct endoscopic access for stone clearance (cholecystoscopy). This approach could theoretically prevent biliary event recurrence similarly to cholecystectomy. The DRECON study (DRainaige, Endoscopic ultrasound, CONservative) is a multicenter, randomized, comparative clinical trial evaluating whether EUS-GBD with LAMS reduces biliary recurrence at 1 year compared to conservative managment (CM) in patients unfit for surgery after a biliary event without acute cholecystitis who are candidates for elective cholecystectomy. Primary hypothesis: EUS-GBD will reduce the risk of biliary event recurrence (biliary colic, acute pancreatitis, cholangitis, choledocholithiasis, or cholecystitis) at 1 year of follow-up compared to conservative management in patients unfit for surgery with gallbladder lithiasis. Estimated sample: 110 patients (55 per arm). Randomization 1:1 (EUS-GBD vs CM), stratified by centre and prior biliary sphincterotomy. Duration: 24 months recruitment + 12 months follow-up (total 3 years). Participating centres: Hospital Universitari Mútua de Terrassa (coordinating centre), Hospital Universitari de Bellvitge, Hospital General de Granollers, Hospital Universitari Parc Taulí de Sabadell, Hospital Universitari de la Santa Creu i Sant Pau, Hospital Clínico Universitario de Valencia, Hospital General Universitario Dr Balmis and Complexo Hospitalario Universitario de A Coruña.

Endoscopic vs Non-endoscopic Drainage for Benign Gallbladder Diseases in High-risk Patients or Patients Desiring Gallbladder Preservation

Common gallbladder conditions like gallstones, polyps, and gallbladder inflammation are typically treated by surgically removing the gallbladder. However, surgery may be too risky for elderly patients or those with severe medical conditions, and some patients strongly prefer to keep their gallbladder. Newer, less-invasive endoscopic treatments can drain the gallbladder to treat inflammation without surgery. However, after successful drainage, doctors currently do not know whether it is better to leave a stent inside for long-term drainage or to actively remove the gallbladder stones using an endoscope. This multicenter study will follow patients in a real-world setting to compare these two approaches: the endoscopic treatment group (stone removal after drainage) and the non-endoscopic treatment group (long-term drainage alone). The goal is to evaluate which method is safer and more effective over the long term, helping doctors make better clinical decisions and improve patients' quality of life.

Tri-Radial Port Extension for Difficult Gallbladder Extraction

Laparoscopic cholecystectomy is a common operation for gallbladder stones. In some patients, the removed gallbladder is difficult to extract through the umbilical port because it is large, thick-walled, or packed with stones. Surgeons commonly enlarge the fascial opening either vertically or horizontally to remove the specimen. These extensions may cause bleeding, tissue trauma, pain, and possible port-site complications. This study compares three methods of enlarging the umbilical fascial opening during difficult gallbladder extraction: vertical fascial extension, horizontal fascial extension, and a new tri-radial fascial micro-incision technique called Tareq's Port Extension (TPE). In TPE, three small radial cuts are made around the fascial opening to create a controlled expansion and facilitate extraction. The study aims to determine whether TPE reduces extraction difficulty, extraction-site bleeding, extraction time, postoperative pain, and port-site complications compared with conventional vertical and horizontal fascial extension techniques. Patients will also be followed for 12 months to assess port-site hernia.

Effect of Erector Spinae Plane Block on Postoperative Respiratory Function After Laparoscopic Cholecystectomy

Postoperative pulmonary dysfunction is frequently observed after laparoscopic abdominal surgery due to the combined effects of general anesthesia, pneumoperitoneum, diaphragmatic dysfunction, and postoperative pain. These factors may impair respiratory mechanics, reduce lung volumes, and negatively affect postoperative recovery. Effective postoperative analgesia plays a crucial role in preserving respiratory function by allowing adequate ventilation and reducing pain-related respiratory limitation. The erector spinae plane (ESP) block is a relatively novel ultrasound-guided fascial plane block that provides thoracoabdominal analgesia through the spread of local anesthetic along the paraspinal fascial planes. By reducing postoperative pain and opioid consumption, ESP block may contribute to improved respiratory mechanics and preservation of postoperative pulmonary function. The aim of this prospective randomized controlled study is to evaluate the effect of ultrasound-guided erector spinae plane block on postoperative respiratory function and pain in patients undergoing elective laparoscopic cholecystectomy. Patients will be randomized into two groups: an ESP block group receiving bilateral ultrasound-guided erector spinae plane block and a control group receiving standard analgesic management. Postoperative respiratory parameters will be evaluated using spirometry measurements including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), the FEV1/FVC ratio, and forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75). In addition, arterial blood gas parameters and postoperative pain scores will be assessed and compared between the groups. The study aims to determine whether ultrasound-guided erector spinae plane block improves postoperative respiratory function and contributes to better postoperative recovery in patients undergoing laparoscopic cholecystectomy.

Feasibility Study of Non-Contact Imaging-Based Physiological Monitoring in the Operating Room

This study aims to evaluate the feasibility and accuracy of a non-contact, camera-based physiological monitoring technology in a perioperative setting (including anesthesia induction, surgery, and recovery).Conventional vital sign monitoring tools-such as ECG leads, blood pressure cuffs, and pulse oximeters-require direct skin contact, which may pose risks of cross-infection or skin injury in vulnerable populations (e.g., newborns or elderly patients). This research utilizes remote Photoplethysmography (rPPG) technology to estimate vital signs, including heart rate, blood pressure, and blood oxygen saturation (SpO2), by analyzing facial video captured via standard camera devices (Logitech C930, iPhone 16 Pro Max, and Samsung Galaxy S24 Ultra).The primary goal is to assess the consistency and stability of this non-contact system compared to clinical gold-standard monitors (Masimo Root, SedLine O3, and Radical-7) during actual surgical procedures. The findings will serve as a foundation for developing non-invasive, supplementary monitoring tools in dynamic clinical environments.

Impact of Pringle Maneuver on Postoperative Gallbladder Diseases After Hepatectomy

The liver is an organ with a rich blood supply. During liver surgery (hepatectomy), surgeons often temporarily clamp the blood vessels supplying the liver to maintain a clear surgical field and reduce bleeding. This common technique is known as the Pringle maneuver. However, this maneuver also temporarily cuts off the blood supply to the gallbladder. Currently, doctors debate whether to routinely remove a healthy gallbladder during liver surgery to prevent future gallbladder problems, or to preserve it. The primary purpose of this multicenter retrospective cohort study is to evaluate whether using the Pringle maneuver during liver surgery increases the risk of patients developing gallbladder diseases (such as gallstones or inflammation) later on. Researchers will review the past medical records of patients who underwent liver surgery with their gallbladder preserved between January 2012 and January 2022. By comparing patients who had the Pringle maneuver with those who did not, the study aims to provide reliable clinical evidence to help surgeons make better decisions about whether to preserve or remove the gallbladder during liver surgery.

Percutaneous Cholangiopancreatoscopy Registry

The Percutaneous Cholangiopancreatoscopy (PCPS) registry is an observational, multicentric, prospective, and retrospective registry of patients undergoing the percutaneous cholangiopancreatoscopy procedure at sites across the United States. In the retrospective component of the study, clinical and procedural data regarding patients who have undergone clinical indicated percutaneous cholangiopancreatoscopy procedure in the past will be collected from all the registry sites and stored in a secure database. The prospective component of the registry will run for three years at each site where patients undergoing the clinically indicated percutaneous cholangiopancreatoscopy procedure will be enrolled in the study, and the patients' data will be collected whenever the patients present to interventional radiology (IR) for a procedure or clinic visit.

Pain Diary Use After Laparoscopic Cholecystectomy

This randomized controlled study aims to evaluate the effectiveness of using a pain diary in the assessment of early postoperative pain in patients undergoing laparoscopic cholecystectomy. Patients will be randomly assigned to a pain diary group or a control group receiving routine pain assessment. Postoperative pain intensity will be measured at predefined time points using standardized pain assessment tools. The study seeks to improve patient participation in postoperative pain evaluation without introducing additional pharmacological interventions.

Intestinal Ischemia Biomarker in Patients With Chronic Mesenteric Ischemia

Plasma Alpha glutathione S transferase (Alpha GST) has been previously demonstrated to be raised in patients with chronic mesenteric ischemia (CMI) caused by atherosclerosis and in patients with median arcuate ligament syndrome (MALS). Raised plasma level of Alpha GST has been demonstrated to decrease or normalize after surgical treatment of patients with CMI and MALS as compared with healthy individuals. This study compares the plasma Alpha GST in patients with CMI and MALS with those with 1-Morbus Crohn, 2-Gallstone disease, and age-matched healthy individuals. Besides, changes in the health-related quality of life (QoL) will be investigated in the study individuals.