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Clinical Trials/NCT02708017
NCT02708017
Completed
N/A

The Analgesic Efficacy of Ultrasound Guided Bilateral Subcostal vs. Posterior Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Aga Khan University0 sites70 target enrollmentMarch 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Subcostal TAP Block for Multiport Laparoscopic Cholecystectomy
Sponsor
Aga Khan University
Enrollment
70
Primary Endpoint
Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study was to compare the analgesic efficacy of the ultrasound guided bilateral subcostal tap block with ultrasound guided bilateral posterior tap block for postoperative analgesia after laparoscopic cholecystectomy

Detailed Description

After approval from Ethics Review Committee, patients were enrolled according to the inclusion and exclusion criteria. Informed written consent for inclusion in the study was taken and during the process,patients were explained about the NRS and other secondary objectives. Blocks were performed under ultrasound guidance immediately after induction of anesthesia.For postoperative analgesia,patients were randomly allocated in two groups using draw/ballot method assigning patients to either of the S-TAP block group or P-TAP-block group. The patients and the staff providing postoperative care and the doctor assessing the pain after surgery were blinded to group assignment. Patients in both groups received standard of care analgesia during the post-operative period i.e., I/V Ketorolac 30mg every 8 hourly, I/V Tramadol 50mg every 8hourly and as per need basis, and I/V Paracetamol 1000mg every 6 hourly Subsequent surgical procedure was performed routinely. After completion of the surgery and emergence from anesthesia, patients were shifted to the Post Anaesthesia Care Unit, and time of arrival in recovery room was taken as 0-hour and noted. Assessment for outcome measures started in recovery room, and continued till 24 hours of the surgery.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
September 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

DR.Karima karam khan

Dr.Karima karam khan

Aga Khan University

Eligibility Criteria

Inclusion Criteria

  • Patients age 18 to 60 years,American society of Anaesthesiology(ASA) class I and II, admitted electively for laparoscopic cholecystectomy

Exclusion Criteria

  • Patients with known allergies to local anesthetics, who were morbidly obese because of difficulty of ultrasound guided approaches for block or having hepato-splenomegaly or any known liver disease, and those whose laparoscopic procedure is converted to open cholecystectomy for any reason

Outcomes

Primary Outcomes

Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours

Time Frame: 24 hours

To compare the mean NRS at 0hr, 1hr, 2 hrs. 6 hrs. 12 hrs. and 24hrs. post-operatively between two groups Numeric rating scale for pain,(0=no pain, 1-3= mild pain, 4-6 moderate pain, 7-10 severe pain.)

Secondary Outcomes

  • Mean opioid consumption postoperatively(24hours)
  • Nausea , vomiting and sedation score(24 hours)
  • Surgical outcome(24 hours)
  • Patient satisfaction(24hours)

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