Application of Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Under Laparoscopic Direct Vision in Laparoscopic Renal Surgery

Not Applicable

Recruiting

• Conditions: Laparoscopic Renal Surgery; Postoperative Pain; Analgesia; Quadratus Lumborum Block

• Registration Number: NCT06550869
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Evaluation of the effectiveness of Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision compared to local infiltration anesthesia for postoperative analgesia after laparoscopic renal surgery in patients.A randomized controlled trial involving 66 patients undergoing laparoscopic renal surgery will assign them randomly to an experimental group or a control group.The patients in experimental group will receive Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision.The patients in control group will receive local infiltration anesthesia.The primary outcome measure is the cumulative consumption of intravenous morphine equivalents at postoperative 24 hours.The secondary outcomes include the cumulative consumption of intravenous morphine equivalents at postoperative 2, 4, 6, 12 and 48 hours, Numeric Rating Scale(NRS) score at rest and during activity (coughing) at postoperative 2, 6, 24 and 48 hours, Global Comfort Questionnaire(GCQ) Comfort Status Scale Score, Quality of Recovery-15(QoR-15) Postoperative Recovery Scale Score, time of the first press on the Patient-Controlled Analgesia pump, nausea, vomiting, skin itching, drowsiness, or other adverse reactions, regional anesthesia-related complications such as local anesthetic toxicity and length of postoperative hospital stay after surgery.

Detailed Description

The patients were 1:1 randomly assigned into groups by a clinical researcher not involved in the clinical procedures or data collection. The random numbers were generated by R studio 4.1.0 (R studio, Boston, MA, USA) software in a 1:1 ratio, with a block size of 8 for each group. The generated random numbers were sealed in opaque envelopes with sequential numbers. On the day of surgery, the envelope was opened by the protocol executor according to the recruitment order before the induction of general anesthesia.Data collection is in the charge of special personnel, and Case Report Form shall be filled in timely after data collection. At the same time, the electronic database was edited by Excel, and the electronic database was entered timely after filling in the paper Case Report form.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-11
• Study First Posted: 2024-08-13
• Study Start: 2024-08-14
• Last Update Submitted: 2024-08-18
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Age: 18 to 80 years old;
• American Society of Anesthesiologists (ASA) physical status classification: I to III;
• Undergoing laparoscopic nephrectomy or partial nephrectomy (including robotic-assisted laparoscopic nephrectomy and partial nephrectomy).

Exclusion Criteria

• Recent use of anticoagulant medications or abnormal coagulation function;
• Local infection at the puncture site or the presence of tumors, severe deformities, or systemic infection;
• Severe renal failure (serum creatinine > 442 μmol/L or requiring renal replacement therapy) or liver dysfunction (Child-Pugh Class C);
• Known allergy to local anesthetics or a family history of local anesthetic allergy;
• Preoperative cognitive impairment or inability to assess pain;
• Alcoholism, drug abuse, chronic opioid dependence, or the use of analgesics or psychotropic medications for more than 3 months;
• History of central and/or peripheral nervous system disorders or myasthenia gravis;
• Planned admission to the ICU;
• Surgical cancellation or patient refusal, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
intravenous morphine equivalents	Postoperative 24 hours	The cumulative consumption of intravenous morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Regional anesthesia-related complications	Postoperative 72 hours	Regional anesthesia-related complications such as local anesthetic toxicity
Global Comfort Questionnaire	Preoperative and postoperative 24 hours	Global Comfort Questionnaire（GCQ） Kolcaba Scale Score,it includes 28 questions,1 is not agree with,4 is very agree with,the total score is 114.
adverse reactions	Postoperative 72 hours	Nausea, vomiting, skin itching, drowsiness, and other adverse reactions
intravenous morphine equivalents	Postoperative 2, 4, 6, 12 and 48 hours	The cumulative consumption of intravenous morphine equivalents
Quality of Recovery-15	Postoperative 24 hours	Quality of Recovery-15（QoR-15） Postoperative Recovery Scale Score,it includes 15 questions,0 is the worst,10 is the best,total score is 150.
Numeric Rating Scale	postoperative 2, 6, 24 and 48 hours	Numeric Rating Scale（NRS） score at rest and during activity (coughing),the pain score is from 0-10,0 is no pain,10 is the most.
Length of hospital stay	Postoperative 10 days	Length of postoperative hospital stay
Time of the first press on Patient-Controlled Analgesia	Postoperative 48 hours	Time of the first press on the Patient-Controlled Intravenous Analgesia pump

Trial Locations

Locations (1)

Second affiliated Hospital School of Medicine,Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China