Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery

Not Applicable

Completed

• Conditions: Postoperative; Pain
• Interventions: Procedure: US-guided Quadratus lumborum block.; Drug: Saline; Drug: Bupivacaine

• Registration Number: NCT04294329
• Lead Sponsor: Ain Shams University

Brief Summary

The purpose of this study was to determine the effectiveness of pre-emptive Quadratus lumborum block on intra, postoperative pain assessment and opioid requirements in laparoscopic bariatric procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-15
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-04
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients included in this study are

• Both genders
• Age between 18-50 years
• Those undergoing laparoscopic bariatric surgery (as laparoscopic sleeve gastrectomy or gastric bypass).
• BMI ≥ 35 Kg/m2 with comorbidity or ≥ 40 Kg/m2 without comorbidity.

Exclusion Criteria

Patients excluded from this study were

• those with obstructive sleep apnoea and/or Pickwickian syndrome.
• if the laparoscopy procedure was converted to laparotomy.
• patients suffering from known coagulation defects.
• known hypersensitivity to bupivacaine, or those with contraindication to the use of NSAIDS.
• Presence of sepsis at the site of injection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Quadratus lumborum block with saline	US-guided Quadratus lumborum block.	After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine.A volume of 0.2ml/kg normal saline will given for each side.
Group Quadratus lumborum block with saline	Saline	After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine.A volume of 0.2ml/kg normal saline will given for each side.
Group Quadratus lumborum block with bupivacaine	US-guided Quadratus lumborum block.	After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine where a solution of 0.25% bupivacaine 0.2 ml /kg (lean body weight) is used on each side with care not to exceed the toxic dose.
Group Quadratus lumborum block with bupivacaine	Bupivacaine	After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine where a solution of 0.25% bupivacaine 0.2 ml /kg (lean body weight) is used on each side with care not to exceed the toxic dose.

Primary Outcome Measures

Name	Time	Method
Postoperative pain severity	24 hours postoperatively	Assessment of analgesia intraoperatively and for the first 24 hours postoperatively using the numerical ratingscale (NRS)score .The scale ranges from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Total dose of opioids	24 hours postoperatively.	Total dose of opioids received in mg
Intraoperative hemodynamics	24 hours postoperatively	Mean arterial pressure (MAP) in mmHg.
Postoperative analgesic needs	24 hours postoperatively.	Time to first analgesic requirement in hours

Trial Locations

Locations (1)

Anesthesiology department, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt