Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732027
• Other study ID #: FMASU R55 /2018
• Status: Completed
• Phase: N/A
• Start date: October 23, 2018
• Est. completion date: January 23, 2020

Study information

• Verified date: August 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total dose of morphine consumption		First 24 hours postoperatively
Secondary	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
Secondary	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