Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients

Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients Undergoing Major Gynecological Surgery: Surgical Transversus Abdominis Plane Block Versus Surgical Rectus Sheath Block

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Surgical Transversus Abdominis Plane Block; Procedure: Surgical Rectus Sheath Block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transversus Abdominis Block [TB] group; Patients will receive Surgical Transversus Abdominis Plane Block	Procedure: Surgical Transversus Abdominis Plane Block; 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.
Active Comparator: Rectus Sheath Block [RB] group; Patients will receive Surgical Rectus Sheath Block	Procedure: Surgical Rectus Sheath Block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total dose of morphine consumption	First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rate scale	Postoperative pain will be assessed at rest and coughing using numerical rate scale (NRS) patients are asked to rate their pain on a scale from 0 to 10, where 0 represents "no pain" and 10 represents "the worst pain possible,".	First 24 hours postoperatively
Postoperative respiratory functions	will be measured using incentive spirometer. Patients were asked to do sustained maximal inspiration (SMI) three times. Then average SMI will be recorded. They will be instructed prior to induction of general anesthesia about the usage of incentive spirometer then a basal measurement will be obtained. After recovery, measurement will be obtained on 60 min, 6 hours, 12 hrs and 24 hrs.	First 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Marwa AK Elbeialy, MD, Faculty of Medicine,Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2018
• Primary Completion (Actual): January 23, 2020
• Study Completion (Actual): January 23, 2020

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 5, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: FMASU R55 /2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No