Clinical Research Directory

The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery

The goal of this single-center, pragmatic, randomized, blinded, placebo-controlled trial is to evaluate the impact of intravenous (IV) lidocaine within the existing Enhanced Recovery After Surgery (ERAS)program on outcomes in patients after major non-cardiac surgery. The main questions the trial aims to answer are: The primary hypothesis is that utilization of IV lidocaine as part of a perioperative multimodal pain regimen will result in a reduction in hospital Case Mix Index-Adjusted Resource Length of Stay (CARLOS). The secondary hypotheses are that lidocaine infusion will result in a reduction in total inpatient opioid consumption (oral morphine milligram equivalents, oMMEs) and pain scores, and improved surgical outcomes (including return of bowel function, ileus, nausea, rapid responses called, surgical site infections, and ICU transfers), while also having minimal incidence of side effects (including double/blurry vision, tinnitus, sedation, and adverse events requiring early cessation).

Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture

The goal of this clinical trial is to learn whether suzetrigine (Journavx®), when added to standard multimodal pain management, can reduce opioid use while providing adequate pain control in adults undergoing surgery for an acute hip fracture. The study will enroll adults aged 18 years or older with femoral neck, intertrochanteric, pertrochanteric, or subtrochanteric hip fractures requiring operative treatment at Beth Israel Deaconess Medical Center. Although enrollment is open to adults aged 18 years and older, the study population is expected to consist predominantly of older adults. The main questions the study aims to answer are: * Does treatment with suzetrigine as part of multimodal pain therapy reduce postoperative opioid consumption, measured as morphine milligram equivalents (MME), during the index hospitalization through 72 hours after surgery or hospital discharge, whichever occurs first? * Does suzetrigine provide effective postoperative pain control and have an acceptable safety and tolerability profile in adults undergoing hip fracture surgery? Researchers will compare participants receiving suzetrigine plus standard multimodal analgesia with matched historical BIDMC patients who underwent similar hip fracture surgery between 2020 and 2025 and received standard multimodal analgesia without suzetrigine. Historical controls will be matched on factors including age, sex, fracture type, surgery type, surgeon, ASA class, opioid-naïve status, regional anesthesia, and relevant comorbidities. Participants in the prospective study will: * Receive a 100-mg oral loading dose of suzetrigine before surgery, followed by 50 mg orally every 12 hours for up to 14 days or until pain resolves, whichever occurs first. * Receive standard multimodal pain management, which may include acetaminophen, nonsteroidal anti-inflammatory medications when appropriate, regional anesthesia, and rescue opioid medication as clinically needed. * Complete pain assessments during hospitalization and at follow-up time points, with opioid use recorded and converted to MME. * Complete follow-up assessments at approximately Days 7, 14, and 28 after surgery, including pain, medication use, adverse events, treatment adherence, and patient-reported outcomes. * Record study medication use, missed doses, rescue opioid use, and adverse events after hospital discharge when applicable.

Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy

The current research is designed to investigate the analgesic efficacy of intravenous ibuprofen on the postoperative analgesic requirements, pain intensity and other recovery parameters.

Transnasal Sphenopalatine Ganglion Block for Postoperative Pain and Recovery in Tonsillectomy (TONwoPA)

The aim of this clinical trial is to evaluate the effectiveness of transnasal transmucosal sphenopalatine ganglion block in reducing post-tonsillectomy pain. The study also investigates its impact on rescue analgesic requirements and postoperative recovery by comparing 5% lidocaine with placebo. Participants will receive a transnasal transmucosal sphenopalatine ganglion block with either 5% lidocaine or placebo (saline). Postoperative pain levels and opioid consumption will be monitored during the first 24 hours after surgery. In addition, length of hospital stay, the occurrence of primary and secondary post-tonsillectomy hemorrhage up to 14 days, unplanned hospital readmissions after discharge, and patient satisfaction on postoperative day 14 will be assessed.

Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study

The goal of this clinical trial is to evaluate whether adding tizanidine to the standard postoperative pain regimen improves recovery after pelvic reconstructive surgery in adult women. The main questions it aims to answer are: Does postoperative tizanidine improve patient-reported recovery 4-6 weeks after surgery? Does tizanidine reduce postoperative pain, opioid use, constipation, and healthcare utilization while improving functional recovery? Researchers will compare standard postoperative care plus tizanidine with standard postoperative care alone to determine whether tizanidine improves postoperative recovery. Participants will: * Be randomly assigned to receive either standard postoperative pain management alone or standard postoperative pain management plus tizanidine for 2 weeks after surgery. * Complete electronic surveys before surgery, 1-2 days after surgery, 2 weeks after surgery, and 4-6 weeks after surgery to assess pain, recovery, activity, and bowel function. * Allow researchers to review information from their electronic medical record, including healthcare utilization and postoperative outcomes, during the 4-6 weeks following surgery.

Comparison of Efficacy of Bupivacaine Alone vs. Bupivacaine-Tramadol in Lower Limb Surgery

This randomized controlled trial aims to compare the effectiveness of bupivacaine alone versus bupivacaine combined with tramadol for postoperative analgesia in patients undergoing lower limb surgeries under spinal anesthesia. A total of 60 patients, aged 18-70 years and classified as ASA I or II, were included and randomly divided into two groups of 30 patients each. The bupivacaine group received 15 mg of 0.75% hyperbaric bupivacaine, while the combination group received 15 mg bupivacaine with 15 mg tramadol. Postoperative pain was assessed using the Visual Analogue Scale (VAS), and the duration of analgesia was recorded as the time from administration of the drug until the patient developed a VAS score of ≥3, indicating the need for rescue analgesia. The findings suggested that adding tramadol to bupivacaine provided better and longer-lasting postoperative pain relief compared with bupivacaine alone.

Low Versus Standard Volume EXORA Block in Laparoscopic Cholecystectomy

The original EXORA block used high local anesthetic volume (50 mL total), raising concerns about local anesthetic systemic toxicity (LAST). In such a bilaterally administered regional technique, evaluating the efficacy of a reduced-volume approach is warranted to maximize patient safety.

Oral Acetaminophen for Post-Op Pain Management in Bariatric Surgery Patients

Adult patients with morbid obesity who have had Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG) surgery have impaired drug metabolism. There is a paucity of information available on how these patients metabolize acetaminophen post operatively and if drug preparation has any effect on achieving adequate pain control. The surgery may alter the stomach pH, reduce surface area of the stomach, affect transit time, and alter anatomic and physiologic standard absorption of medications. Due to these anatomic and physiologic changes, we seek to understand the potential effects of liquid versus pill formulations of acetaminophen on pain control in this patient population. The purpose of this study is to assess for subjective and objective measures of optimized pain control between formulations of acetaminophen including oral pills and oral liquid.

Comparison Between Paravertebral and Erector Spinal Block Efficacy in Robotic Thoracic Surgeries

The overall goal of this work is to find the preferred continues catheter- based thoracic block for patients who undergoing major ROBOTIC assisted thoracic surgery (Lobectomy, multiple segmental resection and thoracotomy). Specifically, this project aims to complete the following: 1. To compare analgesic efficiency of continuous TPVB vs ESP block in patients undergoing major robotic thoracoscopic operation 2. To assess failure rate, time to catheter placement and patient satisfaction of each block group 3. To compare complication rate of each block

Photobiomodulation Therapy for Pain Control in Post-Operative Total Knee Arthroplasty Patients: A Pilot Study

A pilot study to assess the efficacy and feasibility of PBMT for pain control in patients undergoing a TKA and are discharged the same day from an ambulatory surgery center.

Analgesic Efficacy of Combined PECS II and PIP Block Versus Thoracic Paravertebral Block Post-Mastectomy

Postoperative pain management is crucial for patients undergoing mastectomy for breast cancer. Regional analgesia techniques, such as the Thoracic Paravertebral Block (TPVB), are commonly used to reduce pain and opioid consumption; however, TPVB carries potential risks, including pneumothorax. Interfascial plane blocks, specifically the Pectoral Nerve II (PECS II) block combined with the Superficial Parasternal Intercostal Plane (PIP) block, have emerged as alternative techniques to provide comprehensive analgesia to both the lateral and anterior chest wall. The purpose of this randomized controlled trial is to evaluate and compare the analgesic efficacy and quality of postoperative recovery between a combination of ultrasound-guided PECS II and PIP blocks versus the standard Thoracic Paravertebral Block (TPVB) in patients undergoing mastectomy with or without axillary lymph node dissection (ALND). Participants will be randomly assigned to receive either the combined PECS II and PIP block or the TPVB following general anesthesia induction. Pain scores, total opioid consumption, time to first analgesic request, quality of recovery using the QoR-15 questionnaire, and potential block-related complications will be monitored and compared over the 24-hour postoperative period.

A COMPARATIVE STUDY BETWEEN OPIOID-FREE GENERAL ANAESTHESIA AND OPIOID-BASED GENERAL ANAESTHESIA ON THE QUALITY OF RECOVERY IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC HYSTRECTOMY: A Randomized Trial

the intent of this study To compare the efficacy of opioid free general anaesthesia versus opioid based general anaesthesia to achieve enhanced recovery regarding post-operative pain and post-operative nausea and vomiting episodes in patients undergoing elective laparoscopic hysterectomy

Comparison of Post Operative Analgesia in Patients Undergoing Lower Abdominal Surgeries Receiving Ultrasound Guided Block With Dexmetomidine vs Dexmethasone

Lower abdominal surgeries cause significant pain and can be managed by injecting local anesthetic agents between muscles of abdominal wall that can provide post operative pain relief and its duration can be prolonged by adding drugs to local anesthetic regimen

Prevention of Rebound Pain After Orthopaedic Surgery With Peripheral Nerve Block (REBOUND)_part A

Rebound pain after peripheral nerve blocks reduces the benefits of regional anesthesia and increases opioid consumption. This rebound pain most likely results from suboptimal pain management, as patients receiving a peripheral nerve block are typically not given scheduled opioid doses. Oral Patient Controlled Analgesia (PCA) consists of an oral morphine prescription that allows patients to self-administer doses based on their pain score. This study will compare patients undergoing elective orthopaedic surgery under general anaesthesia or sedation with a peripheral nerve block, receiving oral morphine PCA either with or without additional scheduled oral morphine doses.

Prevention of Rebound Pain After Orthopaedic Surgery With Peripheral Nerve Block (REBOUND)_part B

Rebound pain after peripheral nerve blocks reduces the benefits of regional anesthesia and increases opioid consumption. This rebound pain most likely results from suboptimal pain management, as patients receiving a peripheral nerve block are typically not given scheduled opioid doses. Oral Patient Controlled Analgesia (PCA) consists of an oral morphine prescription that allows patients to self-administer doses based on their pain score. This study will compare patients undergoing elective orthopaedic surgery under general anaesthesia or sedation with a peripheral nerve block, receiving oral morphine PCA either with or without additional scheduled oral morphine doses.

Weight-Adjusted Diclofenac Potassium Medicated Lollipop for Post-Adenotonsillectomy Pain in Children

\*\*Brief Summary\*\* This study aimed to develop and conduct a preliminary clinical evaluation of a novel weight-adjusted gelatin-based diclofenac potassium medicated lollipop for the management of postoperative pain following adenotonsillectomy in children. The formulation was designed to improve analgesic adherence by providing a palatable and child-friendly dosage form suitable for oral transmucosal administration. Fifty paediatric patients aged 4 to 12 years undergoing elective adenotonsillectomy received one of three weight-adjusted diclofenac potassium lollipop doses (15 mg, 20 mg, or 30 mg) every 8 hours during the first 24 postoperative hours. The study assessed postoperative pain intensity, product acceptability, rescue analgesic use, and safety. In parallel, the formulation underwent pharmaceutical characterization, including physicochemical and microbiological quality evaluation.

Comparative Study Between Ultrasound Guided Paravertebral Plane Block and Erector Spinae Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy

The intent of this study is to compare the efficacy of the erector spinae plane block (ESPB) and paravertebral plane block in reducing postoperative opioid consumption and pain in patients with total abdominal hysterectomy.

Comparative Study of USG Guided ESPB vs USG Guided PVB For Post-op Analgesia In Patient's After Open Renal Surgeries

Pain control following open renal surgeries are of utmost importance in order to reduce the chance of chronic pain development, and facilitate early rehabilitation. The erector spinae plane block (ESPB) is a recently developed regional anaesthesia procedure successfully used for different types of surgical procedures including open renal surgeries. A Comparative cross-sectional study design will be used and patients fulfilling the inclusion criteria will be included that are admitted through the Outpatient department. Patients will be optimized for surgery. A detailed history will be taken regarding the mode of injury, any preexisting disease and previous surgery and finally thorough examination of the patient will be done to rule out any systemic disease. Informed consent will be taken. These patients will be divided into 2 groups by simple lottery method in group A and B.All the data collected will be entered and analyzed by SPSS version 25.0. Age, surgery d.uration, intraoperative heart rate, intraoperative MAP, total postoperative opioid consumption, total intraoperative opiod and isoflurane consumption, time to first required analgesic, and VAS during the first postoperative 24 h will be summarized, according to normality, into mean (± standard deviation \[SD\]) or median (range). According to data normality, the hypothesis of significant differences between the two studied groups will be challenged using the one-way analysis of variance (with least significant difference correction) or Kruskal-Wallis tests (VAS). Moreover, a p value of \< 0.05 will be regarded to be statistically significant

The Effect of Lactoferrin on Pain Management Following Cesarean Section

This study evaluates whether lactoferrin, a naturally occurring protein with anti-inflammatory and antioxidant properties, can improve pain control after cesarean section. Effective management of postoperative pain is essential to support maternal recovery, mobility, and the ability to care for the newborn, while minimizing reliance on opioid medications and their associated side effects. In this randomized, double-blind, placebo-controlled trial, women undergoing elective cesarean section will receive either oral lactoferrin or a matching placebo in addition to standard postoperative analgesia. Lactoferrin will be administered starting before surgery and continued for 48 hours after delivery. The study will assess whether lactoferrin reduces postoperative pain intensity and opioid consumption, and improves recovery outcomes such as time to mobilization, patient satisfaction, and incidence of common postoperative symptoms. Safety and tolerability will also be evaluated.

Erector Spinae Plane Versus Quadratus Lumborum Blocks for Pain Management After Total Abdominal Hysterectomy

TAH, being a large scale gynaecological operation, is a construction bound to cause serious postoperative pain to the patient in that the procedure will inevitably entail massive tissue dissection. Management of this postoperative pain is of utmost significance because poor analgesia may lead to delayed mobilization of the patient, long duration of hospitalization and also general increase in the morbidity of postoperative period. Traditionally, in these facilities, opioid analgesics are the most common and the most popular means of controlling postoperative pain. Nevertheless, the varied and pervasive use of opioids is largely constrained by its well-reported, dose-dependent systemic adverse effects. Nausea, vomiting, sedation, and respiratory depression are complications that severely degrade the recovery process of the patient and reduce his or her satisfaction.

Preoperative High-Dose Oral Paracetamol for Postoperative Analgesia in Children Undergoing Tonsillectomy"

This randomized clinical trial compares two different preoperative doses of oral paracetamol (acetaminophen) in children undergoing elective tonsillectomy. The aim is to determine whether a higher loading dose (30 mg/kg) decreases the need for opioid rescue medication after surgery compared with the standard dose (15 mg/kg), when used as part of a multimodal pain management approach. Children aged 3 to 15 years will be randomly assigned to receive either 30 mg/kg or 15 mg/kg of oral paracetamol before surgery. All participants will receive the same standard anesthesia and postoperative pain management. The primary outcome is the total amount of rescue opioid (fentanyl) required during the first 12 hours after surgery. Secondary outcomes include postoperative pain scores and the occurrence of side effects such as nausea and vomiting. This study seeks to determine whether a higher initial dose of paracetamol offers additional clinical benefits in pediatric tonsillectomy with multimodal analgesia.

Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP)

Effective postoperative pain management is essential for enhanced recovery after laparoscopic colorectal surgery. This randomized, controlled, double-blind trial will compare conventional postoperative analgesia (intravenous medications plus surgical wound infiltration) with a locoregional strategy combining a peripheral autonomic block (inferior mesenteric and superior hypogastric plexuses) and a transversus abdominis plane (TAP) block. We hypothesize that the combined strategy (BAPTAP) reduces pain intensity and opioid consumption in the first 48 hours after Left-Sided Colorectal Resection.

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

Severe pain associated with thigh and knee fractures makes the positioning for regional anesthesia a challenge. Different modalities to make patient pain free for spinal positioning, post op analgesia and patient satisfaction including supra-inguinal fascia iliaca block (S-FIB) and infra-inguinal fascia iliaca blocks (I-FIB) have been studies. The aim of this study is to compare two blocks in patients undergoing thigh and knee surgeries. A randomized controlled trial study design will be used and 60 patients fulfilling the inclusion criteria will be included. The patients will be divided into 2 groups by simple random sampling. Group A (S-FIB) (n = 30, those who will receive 30 ml of 0.125% bupivacaine) and Group B (I-FIB) (n = 30, those who will receive 30 ml of 0.125% bupivacaine). Depending on the allotted group, patients will be given the block under the guidance of ultrasound in the preoperative area. After block patients will be assessed for ease of spinal positioning using EOSP Scale, postoperative duration of analgesia and patient satisfaction using Likert Scale and data will be recorded on prescribed proforma. All the findings will be noted in a specially designed proforma by the researcher. All the data collected will be entered and analyzed. Quantitative variables will be presented with mean ± SD. Independent sample t-test for duration of postoperative analgesia. Qualitative variables such as ease of spinal positioning and gender will be presented with Chi-Square. A p-value equal to or less than 0.05 will be considered significant.

Supplementary Nerve Blocks Added to the Adductor Canal Block for Postoperative Pain Management in Primary Total Knee Arthroplasty: A Randomized Controlled Comparison of Sciatic, BiFeS, and IPACK Techniques

Postoperative pain following total knee arthroplasty (TKA) is a significant clinical problem that delays early mobilization, reduces patient satisfaction, and increases analgesic requirements. The adductor canal block (ACB), which aims to provide analgesia while preserving motor function, is widely used in postoperative pain management after TKA. However, clinical and anatomical studies have demonstrated that ACB is effective only in the anteromedial sensory innervation of the knee and does not adequately block pain originating from the posterior knee capsule. This limitation reduces analgesic effectiveness, particularly in patients with a prominent posterior pain component. The sciatic nerve block has long been considered the gold standard for managing posterior knee pain. However, due to disadvantages such as motor weakness and delayed rehabilitation, current pain management protocols increasingly favor motor-sparing and complementary approaches such as the Biceps Femoris Short Head (BiFeS) block and the Interspace Between the Popliteal Artery and the Capsule of the posterior Knee (IPACK) block for posterior knee analgesia. In light of this information, the aim of our study is to guide clinical practice by comparing the postoperative analgesic efficacy, motor function outcomes, and patient satisfaction associated with sciatic nerve, BiFeS, and IPACK block techniques-each administered as a supplement to the adductor canal block-in patients undergoing total knee arthroplasty, with the ultimate goal of determining the optimal block combination for postoperative pain control.