Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06550869

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second affiliated Hospital School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Lina Yu, doctor

CONTACT

[email protected]

+8613958033387

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Local infiltration anesthesia

Procedure

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

Primary outcomes

  1. intravenous morphine equivalents

    Time frame: Postoperative 24 hours

    The cumulative consumption of intravenous morphine equivalents

Secondary outcomes

  1. intravenous morphine equivalents

    Time frame: Postoperative 2, 4, 6, 12 and 48 hours

    The cumulative consumption of intravenous morphine equivalents

  2. Numeric Rating Scale

    Time frame: postoperative 2, 6, 24 and 48 hours

    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.

  3. Global Comfort Questionnaire

    Time frame: Preoperative and postoperative 24 hours

    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.

  4. Quality of Recovery-15

    Time frame: Postoperative 24 hours

    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.

  5. Time of the first press on Patient-Controlled Analgesia

    Time frame: Postoperative 48 hours

    Time of the first press on the Patient-Controlled Intravenous Analgesia pump

  6. adverse reactions

    Time frame: Postoperative 72 hours

    Nausea, vomiting, skin itching, drowsiness, and other adverse reactions

  7. Regional anesthesia-related complications

    Time frame: Postoperative 72 hours

    Regional anesthesia-related complications such as local anesthetic toxicity

  8. Length of hospital stay

    Time frame: Postoperative 10 days

    Length of postoperative hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Lina Yu, doctor

CONTACT

[email protected]

+86 13958033387

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.