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NCT07908992

Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy

Sponsor: Beijing Tsinghua Chang Gung Hospital

View on ClinicalTrials.gov

Summary

Percutaneous nephrolithotomy (PCNL) is the preferred minimally invasive procedure for renal stones larger than 2 cm, staghorn calculi and complex stone burdens, but it is frequently associated with moderate-to-severe postoperative pain arising from the incision, renal capsular distension and visceral or stent-related sources. Truncal fascial plane blocks are a key component of opioid-sparing Enhanced Recovery After Surgery (ERAS) pathways. The erector spinae plane block (ESPB) has accrued supportive evidence in PCNL, whereas the intertransverse process block (ITPB) - whose injectate target, the retro-superior costotransverse ligament space, lies closer to the paravertebral space than the ESPB target - has not been directly compared with ESPB in any urological surgery. This is a single-centre, prospective, stratified block-randomised, triple-blind, parallel-group superiority trial. A total of 140 patients undergoing elective unilateral PCNL under general anaesthesia will be randomised 1:1 to receive either ultrasound-guided ITPB or ESPB at the T10-T11 level before induction of anaesthesia, each with 20 mL of 0.375% ropivacaine (75 mg). Both groups will receive an identical intravenous patient-controlled analgesia (PCA) regimen (sufentanil 200 ug in 100 mL, 2 ug/mL; 1 mL bolus, 15-min lockout, no background infusion) for 48 h, with intravenous flurbiprofen axetil 50 mg as rescue. The primary outcome is cumulative opioid consumption over the first 48 postoperative hours, expressed as oral morphine equivalents (OME), calculated as OME (mg) = total sufentanil consumption (ug) x 3. The key secondary outcome is the area under the curve (AUC) of resting pain numeric rating scale (NRS) scores from 0 to 48 h. The hypothesis is that ITPB is superior to ESPB (that is, lower 48-h OME), with an expected between-group difference of -12 mg OME.

Official title: Comparison of Ultrasound-Guided Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy: A Prospective, Stratified Block-Randomised, Triple-Blind, Superiority Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-12

Completion Date

2028-06

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Kidney Stones, Urolithiasis, Hypocitraturia Pain, Postoperative

Interventions

PROCEDURE

Ultrasound-guided intertransverse process block

Single-shot ultrasound-guided intertransverse process block performed after induction of general anaesthesia and before surgical positioning. Under real-time ultrasound guidance a 22-G echogenic needle is advanced in-plane to the intertransverse space at the T10-T11 level and, after negative aspiration, 20 mL of 0.375% ropivacaine is injected. All participants additionally receive a standardised general anaesthetic and postoperative patient-controlled intravenous analgesia with sufentanil, with intravenous flurbiprofen as rescue analgesia.

PROCEDURE

Ultrasound-guided erector spinae plane block

Single-shot ultrasound-guided erector spinae plane block performed after induction of general anaesthesia and before surgical positioning. Under real-time ultrasound guidance a 22-G echogenic needle is advanced in-plane in a cranio-caudal direction to the plane deep to the erector spinae muscle at the T10-T11 level and, after negative aspiration, 20 mL of 0.375% ropivacaine is injected. All participants additionally receive a standardised general anaesthetic and postoperative patient-controlled intravenous analgesia with sufentanil, with intravenous flurbiprofen as rescue analgesia.

Inclusion Criteria: * Age 18 years or older, any sex * Scheduled for elective unilateral percutaneous nephrolithotomy (PCNL) under general anaesthesia, including standard-tract, mini-PCNL and super-mini PCNL * American Society of Anesthesiologists (ASA) physical status I to III * No history of chronic pain (pain lasting more than 3 months, including chronic low back pain or pain of spinal origin) and no long-term opioid use (a daily oral morphine equivalent dose above 30 mg for more than 4 weeks within the 3 months before surgery) * Alert and able to understand and cooperate with postoperative pain scoring, satisfaction assessment and follow-up * Provides written informed consent and is willing to complete the full follow-up Exclusion Criteria: * Known allergy to amide local anaesthetics (ropivacaine, bupivacaine), opioids or flurbiprofen axetil * Skin infection, erythema, swelling or breakdown at the intended puncture site, or a local anatomical abnormality (for example transverse process malformation or scoliosis) that precludes the block * Coagulation disorder: international normalised ratio above 1.5 or platelet count below 80 x 10\^9/L; or current anticoagulant or antiplatelet therapy without the required washout (aspirin at least 5 days, clopidogrel at least 7 days, warfarin until the INR normalises) * Severe hepatic or renal impairment: alanine or aspartate aminotransferase more than twice the upper limit of normal, or serum creatinine more than 1.5 times the upper limit of normal * Pregnancy or breastfeeding (a negative pregnancy test is required before enrolment) * Body mass index above 35 kg/m2 * Severe cardiovascular disease (heart failure, severe arrhythmia, uncontrolled hypertension), respiratory disease (acute exacerbation of chronic obstructive pulmonary disease or asthma) or psychiatric disease that precludes tolerance of surgery and the study procedures * Severe persistent renal colic caused by urinary tract obstruction before surgery, marked hydronephrosis (renal pelvic separation of 2 cm or more on ultrasonography or computed tomography) or renal failure, or previous abdominal surgery that could confound postoperative pain assessment * Refusal to participate or inability to complete the follow-up

Locations (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China