Second affiliated Hospital School of Medicine,Zhejiang University
Hangzhou, Zhejiang, China
Location status: Recruiting
NCT Number: NCT06550869
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The urologists give local infiltration anesthesia with 20 ml of 0.375% ropivacaine hydrochloride injection.
Time frame: Postoperative 24 hours
The cumulative consumption of intravenous morphine equivalents
Time frame: Postoperative 2, 4, 6, 12 and 48 hours
The cumulative consumption of intravenous morphine equivalents
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.
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.
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.
Time frame: Postoperative 48 hours
Time of the first press on the Patient-Controlled Intravenous Analgesia pump
Time frame: Postoperative 72 hours
Nausea, vomiting, skin itching, drowsiness, and other adverse reactions
Time frame: Postoperative 72 hours
Regional anesthesia-related complications such as local anesthetic toxicity
Time frame: Postoperative 10 days
Length of postoperative hospital stay
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Application of Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Under Laparoscopic Direct Vision in Laparoscopic Renal Surgery:A Randomized, Controlled Trial
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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.
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