- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465406
Postoperative Pain Will be Compared in Cholecystectomy Patients: Half Receiving TAP Block and Half Without it.
Comparison Of Patients Post Operative Pain Undergoing Laparoscopic Cholecystectomy Receiving Tap Block Vs Not Receiving Tap Block
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Laparoscopic cholecystectomy is the gold standard for treating symptomatic cholelithiasis; however, patients often experience significant in the early post-operative period. This randomized controlled trial (RCT) was conducted at the Department of Surgery, Liaquat College of Medicine & Dentistry, Karachi, to evaluate the analgesic efficacy of the TAP block.
A total of 60 patients, aged 18-60 years with ASA I or II, were randomized into two equal groups (n=30 each). The intervention group received an TAP block while the control group received standard post-operative analgesia.
The primary objective was to compare the mean Visual Analog Scale (VAS) score at 12 hours post-operation. Secondary objectives included assessing the time to the first request for rescue analgesia and the type of analgesic drug used. Data were analyzed to determine if the TAP block provides superior pain control compared to conventional methods.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Karachi, Pakistan
- Darul Sehat Hospital- Liaquat College of Medicine & Dentistry.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18-60 years
- Both genders
- Patients diagnosed with Cholelithiasis in accordance with operational definition and planned to undergo Laparoscopic Cholecystectomy
Exclusion Criteria:
- Patients with ASA of ≥ 3
- Patients diagnosed with acute cholecystitis, empyema, mucocele or perforated gall bladder
- Patients planned to undergo laparoscopic cholecystectomy alongside other abdominal procedures
- Patients with body mass index of ≥ 35 Kg/m2
- Patients with history of coagulation disorders like hemophilia or those with history of anti-platelet drugs use in last 2 weeks
- Pregnant females
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TAP Block Group
Patients in this group received a Transversus Abdominis Plane (TAP) block at the end of the laparoscopic cholecystectomy but before extubation.
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Transversus Abdominis Plane (TAP) block administered by injecting 20ml of 0.25% Bupivacaine between the internal oblique and transversus abdominis muscles.
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Other: Control Group (The No TAP Block Group)
Patients in this group underwent laparoscopic cholecystectomy under the same general anesthesia protocol but did not receive a TAP block
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Patients received the routine post-operative analgesia protocol of the hospital (e.g., IV Ketorolac or Paracetamol) without the administration of a TAP block
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS) Score for Pain
Time Frame: 12 hours post-operation
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A subjective psychometric response scale used to measure pain intensity.
It consists of a 10 cm line where 0 represents "no pain" and 10 represents "the worst pain imaginable.".
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12 hours post-operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time for First Request of Rescue Analgesia
Time Frame: Within the first 24 hours post-operation.
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The duration of time (in hours or minutes) from the end of the surgical procedure until the patient first requests additional pain medication due to inadequate pain control.
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Within the first 24 hours post-operation.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- DarulSehatH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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