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

NCT06550869 | Recruiting

• 1 other identifier: 2024-0806
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• intravenous morphine equivalents

  The cumulative consumption of intravenous morphine equivalents

  Postoperative 24 hours

Secondary Outcomes (8)

• intravenous morphine equivalents

  Postoperative 2, 4, 6, 12 and 48 hours

• Numeric Rating Scale

  postoperative 2, 6, 24 and 48 hours

• Global Comfort Questionnaire

  Preoperative and postoperative 24 hours

• Quality of Recovery-15

  Postoperative 24 hours

• Time of the first press on Patient-Controlled Analgesia

  Postoperative 48 hours

Study Arms (2)

QLB-LSAL

EXPERIMENTAL

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

LA

ACTIVE COMPARATOR

The patient received local infiltration anesthesia.

Procedure: Local infiltration anesthesia

Interventions

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

QLB-LSAL

Local infiltration anesthesia PROCEDURE

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

LA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated Hospital School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Lina Yu, doctor

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

  STUDY DIRECTOR

Central Study Contacts

Lina Yu, doctor

CONTACT

+86 13958033387; zryulina@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 13, 2024
• Study Start: August 14, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)