Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery

NCT ID: NCT04294329

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2020-03-31

Brief Summary

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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

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Conditions

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Pain Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group Quadratus lumborum block with 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.

Group Type EXPERIMENTAL

US-guided Quadratus lumborum block.

Intervention Type PROCEDURE

Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery

Bupivacaine

Intervention Type DRUG

Bupivacaine

Group Quadratus lumborum block with 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 Type PLACEBO_COMPARATOR

US-guided Quadratus lumborum block.

Intervention Type PROCEDURE

Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery

Saline

Intervention Type DRUG

normal saline

Interventions

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US-guided Quadratus lumborum block.

Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery

Intervention Type PROCEDURE

Bupivacaine

Bupivacaine

Intervention Type DRUG

Saline

normal saline

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Walid Nofal

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed S. Omran, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology department, Faculty of Medicine, Ain Shams University

Doaa M. Kamal El-Din, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology department, Faculty of Medicine, Ain Shams Unive

Walid H. Nofal, MD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology department, Faculty of Medicine, Ain Shams Unive

Locations

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Anesthesiology department, Faculty of Medicine, Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU R 18/2017

Identifier Type: -

Identifier Source: org_study_id

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