Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery

Pain Clinical Trial

Official title:

Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery.A Prospective Randomizes Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294329
• Other study ID #: FMASU R 18/2017
• Status: Completed
• Phase: N/A
• Start date: August 15, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: August 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Postoperative

Intervention

Procedure:
• US-guided Quadratus lumborum block.
Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery

Drug:
• Bupivacaine
Bupivacaine
• Saline
normal saline

Locations

Country	Name	City	State
Egypt	Anesthesiology department, Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain severity	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.	24 hours postoperatively
Secondary	Intraoperative hemodynamics	Mean arterial pressure (MAP) in mmHg.	24 hours postoperatively
Secondary	Postoperative analgesic needs	Time to first analgesic requirement in hours	24 hours postoperatively.
Secondary	Total dose of opioids	Total dose of opioids received in mg	24 hours postoperatively.