CompletedNCT04294329Updated Aug 25, 2020

Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery

An interventional study of US-guided Quadratus lumborum block. and Bupivacaine in Pain and Postoperative, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-25.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

From the registry’s dates

Registered 2 years 5 months after the study started (first participant enrolled Aug 2017, registered Feb 2020).

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Conditions studied

Pain
Postoperative

Keywords

Quadratus lumborum block
laparoscopic bariatric surgery

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Experimental
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.
Procedure: US-guided Quadratus lumborum block. · Drug: Bupivacaine
Placebo comparator
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.
Procedure: US-guided Quadratus lumborum block. · Drug: Saline

Interventions

ProcedureUS-guided Quadratus lumborum block.
Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery
DrugBupivacaine
Bupivacaine
DrugSaline
normal saline

What researchers measure

Primary outcomes

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.
Time frame: 24 hours postoperatively

Secondary outcomes

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

Study locations

1 site

Anesthesiology department, Faculty of Medicine, Ain Shams University
Cairo, Egypt

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04294329
Lead sponsor: Ain Shams University
Responsible party: Walid Nofal (Clinical professor, Ain Shams University) — Principal investigator
First posted: Mar 4, 2020
Start date: Aug 15, 2017
Primary completion: Mar 15, 2020
Completion: Mar 31, 2020
Last update: Aug 25, 2020

Study contacts

Ahmed S. Omran, MD

principal investigator · Anesthesiology department, Faculty of Medicine, Ain Shams University

Doaa M. Kamal El-Din, MD

principal investigator · Anesthesiology department, Faculty of Medicine, Ain Shams Unive

Walid H. Nofal, MD

principal investigator · Anesthesiology department, Faculty of Medicine, Ain Shams Unive

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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