Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT05141955

Collaborator

(none)

120

Enrollment

Location

Arms

Actual Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postoperative pain control is a signiﬁcant challenge in medical practice. Inadequate pain control could decrease patient's satisfaction, delay postoperative ambulation, increase the incidence of pulmonary and cardiac complications and cause the development of chronic postoperative pain. Laparoscopic surgical techniques could decrease postoperative pain and opioid consumption.

The addition of regional techniques to general anesthesia showed better pain management and less consumption of opioids compared to the traditional techniques.

The aim of this study is to compare the effectiveness of ultrasound guided erector spinae plane block versus quadratus lumborum block regarding postoperative analgesia in patients undergoing laparoscopic sleeve gastrectomy.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Other: Group Erector Spinae Plane Block (ESPB) Other: Group Quadratus Lumborum Block (QLB) Other: Group (C) (Control group)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

A Randomized Controlled Trial for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block

Actual Study Start Date :

Dec 15, 2021

Actual Primary Completion Date :

Jun 15, 2022

Actual Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group Erector Spinae Plane Block (ESPB)	Other: Group Erector Spinae Plane Block (ESPB) Patients will receive general anesthesia initially then bilateral ESPB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed (not exceeding toxic dose) 150 mg "
Active Comparator: Group Quadratus Lumborum Block (QLB)	Other: Group Quadratus Lumborum Block (QLB) Patients will receive general anesthesia initially then bilateral QLB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed "not exceeding toxic dose150 mg "
Other: Group (C) (Control group)	Other: Group (C) (Control group) Where patients will be operated under general anesthesia.

Arm

Intervention/Treatment

Active Comparator: Group Erector Spinae Plane Block (ESPB)

Other: Group Erector Spinae Plane Block (ESPB)

Patients will receive general anesthesia initially then bilateral ESPB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed (not exceeding toxic dose) 150 mg "

Active Comparator: Group Quadratus Lumborum Block (QLB)

Other: Group Quadratus Lumborum Block (QLB)

Patients will receive general anesthesia initially then bilateral QLB with a total volume of (0.3-0.4 ml/kg LBW) of bupivacaine 0.25% will be performed "not exceeding toxic dose150 mg "

Other: Group (C) (Control group)

Other: Group (C) (Control group)

Where patients will be operated under general anesthesia.

Outcome Measures

Primary Outcome Measures

Time to first requested rescue analgesia(Minutes) [24 hours postoperatively]
Time to first requested rescue analgesia(Minutes)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with free medical history or controlled hypertension and/ or diabetes scheduled for elective laparoscopic sleeve gastrectomy.
BMI > 35 kg/ m2

Exclusion Criteria:

Patients unfit for surgery or refuse to sign the consent of regional block.
Patients with known coagulation defects.
Patients with known hypersensitivity to bupivacaine.
Patients with infection at the site of injection.
Conversion of laparoscopic surgery to laparotomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain-Shams University Hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr.Ibrahim Mamdouh Esmat, Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt., Ain Shams University

ClinicalTrials.gov Identifier:

NCT05141955

Other Study ID Numbers:

FMASU MS 705/ 2021

First Posted:

Dec 2, 2021

Last Update Posted:

Jun 28, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jun 28, 2022