Back to resultsAnterior Abdominal Blocks for Postoperative Pain Control in Obese Patients
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Surgical Transversus Abdominis Plane Block
Surgical Rectus Sheath Block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
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
Sites / Locations
- Ain Shams University hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transversus Abdominis Block [TB] group
Rectus Sheath Block [RB] group
Arm Description
Patients will receive Surgical Transversus Abdominis Plane Block
Patients will receive Surgical Rectus Sheath Block
Outcomes
Primary Outcome Measures
Total dose of morphine consumption
Secondary Outcome Measures
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,".
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03732027
Brief Title
Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transversus Abdominis Block [TB] group
Arm Type
Active Comparator
Arm Description
Patients will receive Surgical Transversus Abdominis Plane Block
Arm Title
Rectus Sheath Block [RB] group
Arm Type
Active Comparator
Arm Description
Patients will receive Surgical Rectus Sheath Block
Intervention Type
Procedure
Intervention Name(s)
Surgical Transversus Abdominis Plane Block
Intervention Description
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
Intervention Name(s)
Surgical Rectus Sheath Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total dose of morphine consumption
Time Frame
First 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Numerical rate scale
Description
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,".
Time Frame
First 24 hours postoperatively
Title
Postoperative respiratory functions
Description
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.
Time Frame
First 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa AK Elbeialy, MD
Organizational Affiliation
Faculty of Medicine,Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients
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