Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients

NCT ID: NCT03732027

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2020-01-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Transversus Abdominis Block [TB] group

Patients will receive Surgical Transversus Abdominis Plane Block

Group Type: ACTIVE_COMPARATOR

Surgical Transversus Abdominis Plane Block

Intervention Type: 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.

Rectus Sheath Block [RB] group

Patients will receive Surgical Rectus Sheath Block

Group Type: ACTIVE_COMPARATOR

Surgical Rectus Sheath Block

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Ahmed Khairy Elbeialy

Lecturer of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa AK Elbeialy, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine,Ain Shams University

Locations

Ain Shams University hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMASU R55 /2018

Identifier Type: -

Identifier Source: org_study_id