Clinical trial NCT06550869: Application of Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Under Laparoscopic Direct Vision in Laparoscopic Renal Surgery
Official title: Application of Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Under Laparoscopic Direct Vision in Laparoscopic Renal Surgery：A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Analgesia
Quadratus Lumborum Block
Laparoscopic Renal Surgery
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: intravenous morphine equivalents
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: intravenous morphine equivalents
timeFrame: Postoperative 2, 4, 6, 12 and 48 hours
measure: Numeric Rating Scale
timeFrame: postoperative 2, 6, 24 and 48 hours
measure: Global Comfort Questionnaire
timeFrame: Preoperative and postoperative 24 hours
measure: Quality of Recovery-15
timeFrame: Postoperative 24 hours
measure: Time of the first press on Patient-Controlled Analgesia
timeFrame: Postoperative 48 hours
measure: adverse reactions
timeFrame: Postoperative 72 hours
measure: Regional anesthesia-related complications
timeFrame: Postoperative 72 hours
measure: Length of hospital stay
timeFrame: Postoperative 10 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated Hospital School of Medicine,Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Lina Yu, doctor
role: STUDY_DIRECTOR
References: