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

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Zhejiang University

Status

Enrolling

Conditions

Postoperative Pain
Quadratus Lumborum Block
Laparoscopic Renal Surgery
Analgesia

Treatments

Procedure: Local infiltration anesthesia
Procedure: Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision

Study type

Interventional

Funder types

Other

Identifiers

NCT06550869
2024-0806

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

66 participants in 2 patient groups

QLB-LSAL
Experimental group
Description:
The patient received Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision.
Treatment:
Procedure: Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision
LA
Active Comparator group
Description:
The patient received local infiltration anesthesia.
Treatment:
Procedure: Local infiltration anesthesia

Trial contacts and locations

1

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Central trial contact

Lina Yu, doctor

Data sourced from clinicaltrials.gov

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