Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients

NCT03732027 | Completed

• 1 other identifier: FMASU R55 /2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare between two surgical techniques for anterior abdominal wall blocks in obese patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane \[TAP\] block versus Rectus Sheath block as regards the efficacy and adverse effects

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Total dose of morphine consumption

  First 24 hours postoperatively

Secondary Outcomes (2)

• Numerical rate scale

  First 24 hours postoperatively

• Postoperative respiratory functions

  First 24 hours postoperatively

Study Arms (2)

Transversus Abdominis Block [TB] group

ACTIVE COMPARATOR

Patients will receive Surgical Transversus Abdominis Plane Block

Procedure: Surgical Transversus Abdominis Plane Block

Rectus Sheath Block [RB] group

ACTIVE COMPARATOR

Patients will receive Surgical Rectus Sheath Block

Procedure: Surgical Rectus Sheath Block

Interventions

Surgical Transversus Abdominis Plane Block PROCEDURE

At the end of operation and after hemostasis, 20 ml of 0.25% bupivacaine will be injected intra-abdominally into the Transversus Abdominis plane at the midpoint of the line connecting the crista iliaca and inferior costal margin and at two locations in the lateral abdominal wall at 3-4 cm inferior to the previous midline injection. The same procedure will be repeated on the opposite side using an identical amount of local anesthetic.

Transversus Abdominis Block [TB] group

Surgical Rectus Sheath Block PROCEDURE

At the end of operation and after hemostasis,20 ml 0.25% bupivacaine will be administered slowly under direct vision after careful aspiration to the rectus sheath space which is present inbetween rectus abdominis muscle and the posterior layer of its sheath at the upper pole of the midline incision by time of closure of the anterior abdominal wall. The procedure will be repeated on the opposite side.

Rectus Sheath Block [RB] group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients
• undergoing major gynecological surgery with supraumbilical midline incision the first time
• Body mass index (BMI) more than 40.

You may not qualify if:

• patient refusal to participate in the study,
• reoperation,
• addiction
• alcohol abuse
• hypersensitivity or allergy to the study drugs

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marwa AK Elbeialy, MD

  Faculty of Medicine,Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: November 6, 2018
• Study Start: October 23, 2018
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: August 23, 2021

Record last verified: 2021-08

Locations

EG (1)