- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07606781
Combination of Superior Hypogastric Plexus Block and Transversus Abdominis Plane Block in Abdominal Hysterectomies
Analgesic Effect of Combination of Superior Hypogastric Plexus Block and Transversus Abdominis Plane Block in Abdominal Hysterectomies: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Abdominal hysterectomy is a major surgery that is often associated with pronounced postsurgical pain. Inadequate postoperative analgesia can lead to postoperative complications and can delay functional recovery. Accordingly, a multimodal regimen for postoperative pain management is recommended.
The transverse abdominis plane (TAP) block is a regional block anesthetizing the nerves (T10 to L1) hence covering the lower abdominal wall.
The superior hypogastric plexus (SHP), which lies retroperitoneally in front of the L5 and S1 vertebrae, provides innervation to the pelvic viscera. The blockade of SHP is well-recognized for the management of chronic pelvic pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammed S Elsharkawy, MD
- Phone Number: 00201148207870
- Email: mselsharkawy@med.tanta.edu.eg
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
Contact:
- Mohammed S Elsharkawy, MD
- Phone Number: 00201148207870
- Email: mselsharkawy@med.tanta.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years.
- American Society of Anesthesiology (ASA) physical status I-II.
- Undergoing abdominal hysterectomies under general anesthesia (GA).
Exclusion Criteria:
- History of allergies to local anesthetics.
- Body mass index (BMI) >35 kg/m2.
- Opioid dependency.
- Cognitive impairment.
- Bleeding or coagulation disorders.
- Psychiatric and neurological disorder.
- Local infection at the site of injection.
- Severe heart, lung, liver, and renal dysfunction.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group S
Patients will receive superior hypogastric plexus block (SHPB) using 20ml of bupivacaine 0.25%+ transverse abdominis plane (TAP) block using 20ml of bupivacaine 0.25%.
|
Patients will receive superior hypogastric plexus block (SHPB) using 20ml of bupivacaine 0.25%+ transverse abdominis plane (TAP) block using 20ml of bupivacaine 0.25%.
|
|
Active Comparator: Group C
Patients will receive superior hypogastric plexus block (SHPB) using 20ml of saline 0.9% (sham)+ transverse abdominis plane (TAP) block using 20ml of bupivacaine 0.25%.
|
Patients will receive superior hypogastric plexus block (SHPB) using 20ml of saline 0.9% (sham)+ transverse abdominis plane (TAP) block using 20ml of bupivacaine 0.25%.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to the first request for the rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to the first request for the rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.
|
24 hours postoperatively
|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS).
NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
NRS will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 8, 12, 18, and 24 h postoperatively.
|
24 hours postoperatively
|
|
Incidence of adverse events
Time Frame: 24 hours postoperatively
|
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, pruritus, or any other complication will be recorded.
|
24 hours postoperatively
|
|
Quality of recovery
Time Frame: 24 hours postoperatively
|
The quality of recovery (QoR-15) score will be assessed 24 hours postoperatively.
This tool consists of 15 questions, each scored on a 10-point scale, yielding a maximum of 150.
It encompasses five domains; physical comfort (questions 1-4, 13), emotional state (questions 9, 10, 14, 15), psychological support (questions 6, 7), physical independence (questions 5, 8), and pain (questions 11, 12).
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 36265PR2/4/26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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