NCT04294329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

2.6 years

First QC Date

February 14, 2020

Last Update Submit

August 24, 2020

Conditions

PainPostoperative

Keywords

Quadratus lumborum blocklaparoscopic bariatric surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Intraoperative hemodynamics

    24 hours postoperatively

  • Postoperative analgesic needs

    24 hours postoperatively.

  • Total dose of opioids

    24 hours postoperatively.

Study Arms (2)

Group Quadratus lumborum block with bupivacaine

EXPERIMENTAL

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.

Procedure: US-guided Quadratus lumborum block.Drug: Bupivacaine

Group Quadratus lumborum block with saline

PLACEBO COMPARATOR

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.

Procedure: US-guided Quadratus lumborum block.Drug: Saline

Interventions

US-guided Quadratus lumborum block.PROCEDURE

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

Group Quadratus lumborum block with bupivacaineGroup Quadratus lumborum block with saline
BupivacaineDRUG

Bupivacaine

Group Quadratus lumborum block with bupivacaine
SalineDRUG

normal saline

Group Quadratus lumborum block with saline

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology department, Faculty of Medicine, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ahmed S. Omran, MD

    Anesthesiology department, Faculty of Medicine, Ain Shams University

    PRINCIPAL INVESTIGATOR

  • Doaa M. Kamal El-Din, MD

    Anesthesiology department, Faculty of Medicine, Ain Shams Unive

    PRINCIPAL INVESTIGATOR

  • Walid H. Nofal, MD

    Anesthesiology department, Faculty of Medicine, Ain Shams Unive

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

February 14, 2020

First Posted

March 4, 2020

Study Start

August 15, 2017

Primary Completion

March 15, 2020

Study Completion

March 31, 2020

Last Updated

August 25, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)