- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482709
Comparison Between Tranversus Abdominis Plane (TAP) Block With Only Bupivacaine and TAP Block With Bupivacaine Plus Ketamine in Reducing Postoperative Pain After Total Abdominal Hystrectomy (TAP-BvsBK-TAH)
Transversus Abdominis Plane Block : A Comparative Study Between Bupivacaine vs Bupivacaine With Ketamine in Total Abdominal Hystrectomy
The goal of this study is to know how effectively TAP block can reduce postoperative pain in total abdominal hystrectomy patients when given ketamine in addition to bupivacaine in TAP block and to compare it with the conventional TAP block with bupivacaine only. The main question it aims to answer is:
Does intervention with ketamine in TAP block lowers the postoperative pain measured via visual analog scale and decreases the need for rescue analgesia?
Patients will be assessed for pain in PACU( post anesthesia care unit), 6 hours, 12 hours and 24 hours postoperatively. Time of rescue analgesia will also be noted if given.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 74800
- Recruiting
- gynae operation theatre at Liaquat National Hospital
-
Contact:
- gynae theatre
- Phone Number: (021)111-456-456
- Email: admin@lnh.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 25 to 60 years.
- ASA grade I & II.
- Undergoing total abdominal hysterectomy.
Exclusion Criteria:
- BMI >35kg/m2.
- Patient refusal for participation.
- Patients with coagulation disorders.
- Patents with history of allergy and hypersensitivity to local anesthetic.
- Patient having infection at the injection site.
- Alcohol or drug abuse.
- Cognitive or mental disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TAP block with bupivacaine only
|
20ml of 0.25% bupivacaine inTAP block
|
|
Experimental: TAP block with bupivacaine plus ketamine
|
20ml of 0.25% of bupivacaine with 50mg ketamine in TAP block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS score
Time Frame: At PACU(5 mins after shifting to PACU), 6,12 and 24 hours post-operatively
|
VAS (visual analog scale ) score noted VAS of <2 = no pain VAS of 2-4 = mild pain VAS of 5-6 = moderate pain VAS of >6 = severe pain
|
At PACU(5 mins after shifting to PACU), 6,12 and 24 hours post-operatively
|
|
Time of receiving first rescue analgesia
Time Frame: within first 24 hours postoperatively
|
time for additional requirment of inj.
tramadol 50mg for post operative pain relief
|
within first 24 hours postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- URahim
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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