Clinical trial NCT02708017: Analgesic Effect of Subcostal TAP Block
Official title: The Analgesic Efficacy of Ultrasound Guided Bilateral Subcostal vs. Posterior Transversus Abdominis Plane Block After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subcostal TAP Block for Multiport Laparoscopic Cholecystectomy
Keywords: Subcostal TAP block
Posterior TAP block
Ultrasound
Laparoscopic cholecystectomy
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: Mean postoperative static and dynamic numeric rating scale (NRS) at 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Mean opioid consumption postoperatively
timeFrame: 24hours
measure: Nausea , vomiting and sedation score
timeFrame: 24 hours
measure: Surgical outcome
timeFrame: 24 hours
measure: Patient satisfaction
timeFrame: 24hours
Other outcomes:
Locations:
Study officials:
affiliation: Aga Khan University
name: Karima K Khan, FCPS
role: PRINCIPAL_INVESTIGATOR
References: