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

Application of Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Under Laparoscopic Direct Vision in Laparoscopic Renal Surgery：A Randomized, Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Analgesia; Quadratus Lumborum Block; Laparoscopic Renal Surgery
• Intervention / Treatment: Procedure: Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision; Procedure: Local infiltration anesthesia

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 Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Yu, doctor; Phone Number: +86 13958033387; Email: zryulina@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Second affiliated Hospital School of Medicine,Zhejiang University
      • Contact: Lina Yu, doctor; Phone Number: +8613958033387; Email: zryulina@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLB-LSAL; The patient received Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision.	Procedure: Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision; The urologists find the inner arcuate ligament. The scalp needle is inserted from the midpoint of the lower edge of the inner or outer arcuate ligament towards the head to the dorsal side of the diaphragm. After withdrawing without blood, air, or cerebrospinal fluid, 2 ml of normal saline is first administered to observe the fluid spreading towards the head Then, 20 ml of 0.375% ropivacaine hydrochloride injection is administered.
Active Comparator: LA; The patient received local infiltration anesthesia.	Procedure: Local infiltration anesthesia; The urologists give local infiltration anesthesia with 20 ml of 0.375% ropivacaine hydrochloride injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intravenous morphine equivalents	The cumulative consumption of intravenous morphine equivalents	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intravenous morphine equivalents	The cumulative consumption of intravenous morphine equivalents	Postoperative 2, 4, 6, 12 and 48 hours
Numeric Rating Scale	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.	postoperative 2, 6, 24 and 48 hours
Global Comfort Questionnaire	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.	Preoperative and postoperative 24 hours
Quality of Recovery-15	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.	Postoperative 24 hours
Time of the first press on Patient-Controlled Analgesia	Time of the first press on the Patient-Controlled Intravenous Analgesia pump	Postoperative 48 hours
adverse reactions	Nausea, vomiting, skin itching, drowsiness, and other adverse reactions	Postoperative 72 hours
Regional anesthesia-related complications	Regional anesthesia-related complications such as local anesthetic toxicity	Postoperative 72 hours
Length of hospital stay	Length of postoperative hospital stay	Postoperative 10 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Lina Yu, doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2024-0806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No