Anterior Abdominal Blocks for Postoperative Pain Control in Obese Patients
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03732027 |
|
Recruitment Status :
Completed
First Posted : November 6, 2018
Last Update Posted : August 23, 2021
|
Sponsor:
Ain Shams University
Information provided by (Responsible Party):
Marwa Ahmed Khairy Elbeialy, Ain Shams University
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Pain | Procedure: Surgical Transversus Abdominis Plane Block Procedure: Surgical Rectus Sheath Block | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | October 23, 2018 |
| Actual Primary Completion Date : | January 23, 2020 |
| Actual Study Completion Date : | January 23, 2020 |
| 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. |
Primary Outcome Measures :
- Total dose of morphine consumption [ Time Frame: First 24 hours postoperatively ]
Secondary Outcome Measures :
- Numerical rate scale [ Time Frame: First 24 hours postoperatively ]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 [ Time Frame: First 24 hours postoperatively ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732027
Locations
| Egypt | |
| Ain Shams University hospitals | |
| Cairo, Egypt, 11591 | |
Sponsors and Collaborators
Ain Shams University
Investigators
| Principal Investigator: | Marwa AK Elbeialy, MD | Faculty of Medicine,Ain Shams University |
| Responsible Party: | Marwa Ahmed Khairy Elbeialy, Lecturer of Anesthesia, Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT03732027 |
| Other Study ID Numbers: |
FMASU R55 /2018 |
| First Posted: | November 6, 2018 Key Record Dates |
| Last Update Posted: | August 23, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |