Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Dexmedetomidine; Bupivacaine; Ultrasound-Guided; Quadratus Lumborum Block; Postoperative Analgesia; Laparoscopic Cholecystectomy
• Interventions: Drug: Bupivacaine; Drug: Bupivacaine and Dexmedetomidinc) group

• Registration Number: NCT06825286
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to evaluate the effect of adding Dexmedctomidinc as adjuvant to Bubivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy.

Detailed Description

When compared to conventional surgery, laparoscopic cholecystectomy is less invasive and leads to less postoperative pain. However, the postoperative pain following laparoscopic cholecystectomy consists of both somatic and visceral components with pain originating from port entry' wounds, gallbladder resection and abdominal insufflation that leads to peritoneal distention and peritoneal damage.

Quadratus lamborum block (QLB) is abdominal truncal block that provides both somatic and visceral analgesia for both upper and lower abdominal surgical procedures, It was first introduced by Blanco.Currently There are 4 approaches described for QLB: lateral, posterior, anterior and intramuscular. Transmuscular (anterior) QLB Type 3 block involves injection in the plane between the psoas major (PM) and the QL muscles studies have reported spread of the injectate to the thoracic paravertebral space, as well as the spinal nerve which runs anterior to the QL muscle

Study Timeline

• Study Start: 2023-08-01
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-08
• Study First Submitted QC: 2025-02-08
• Last Update Submitted: 2025-02-08
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Aged 21-65 years.
• Both genders.
• American society of Anesthesiology (ASA) class l, II undergoing elective laparoscopic cholecystectomy

Exclusion Criteria

• Patient refusal
• History of allergy to local anesthetic.
• Liver or renal pathology affecting drug elimination
• Menta!dysfunction or cognitive disorders.
• Patients on chronic pain medications.
• Body Mass Index > 40 kg/m2.
• Coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine group	Bupivacaine	Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20 ml bupivacaine 0.25%)
Bupivacaine and Dexmedetomidinc group	Bupivacaine and Dexmedetomidinc) group	Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine I mic/kg)

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	24 hours postoperatively	Intravenous morphine 2 mg given when numerical rating scale equal or above 4 as rescue analgesia

Secondary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	At the end of the operation(Up to 48 min).	Mean arterial blood pressure was recorded before the block (base-line value), after skin incision by 5,15,30 minutes, and at the end of the operation.
Heart rate	At the end of the operation (Up to 48 min).	Heart rate was recorded before the block (base-line value), after skin incision by 5,15,30 minutes, and at the end of the operation.
lntraoperative fentanyl consumption	lntraoperatively	Additional fentanyl dosages of 0.5 µg/kg IV was administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Degree of pain score	24 hours postoperatively	Postoperative pain was assessed by the numerical rating scale (NRS; 0 no pain while 10 is the maximum pain) immediately after discharge to the PACU and ward at 6, 12, 18, 24 hours.
Time to the first request for the rescue analgesia	24 hours postoperatively	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).IV morphine 2mg was given when NRS equal or above 4.
Incidence of Complication	24 hours postoperatively	Complication such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, ElGharbia, Egypt