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

NCT ID: NCT06550869

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-14
• Study Completion Date: 2025-08-31

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.

Conditions

Postoperative Pain; Analgesia; Quadratus Lumborum Block; Laparoscopic Renal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

QLB-LSAL

The patient received Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision.

Group Type: EXPERIMENTAL

Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision

Intervention Type: PROCEDURE

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.

LA

The patient received local infiltration anesthesia.

Group Type: ACTIVE_COMPARATOR

Local infiltration anesthesia

Intervention Type: PROCEDURE

The urologists give local infiltration anesthesia with 20 ml of 0.375% ropivacaine hydrochloride injection.

Interventions

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.

Intervention Type: PROCEDURE

Local infiltration anesthesia

The urologists give local infiltration anesthesia with 20 ml of 0.375% ropivacaine hydrochloride injection.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lina Yu, doctor

Role: STUDY_DIRECTOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

Second affiliated Hospital School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lina Yu, doctor

Role: CONTACT

zryulina@zju.edu.cn

+86 13958033387

Facility Contacts

Lina Yu, doctor

Role: primary

zryulina@zju.edu.cn

+8613958033387

Other Identifiers

2024-0806

Identifier Type: -

Identifier Source: org_study_id