Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

Phase 4

Completed

• Conditions: Cholecystectomy, Laparoscopic; Pain, Postoperative
• Interventions: Drug: Levobupivacaine 0.25 %; Drug: Levobupivacaine 0.5%

• Registration Number: NCT02185716
• Lead Sponsor: Duzce University

Brief Summary

Postoperative pain is a significant cause of increased morbidity in the perioperative period, leading to patient discomfort and greater hospital length of stay. Laparoscopic cholecystectomy associated with significant postoperative pain, a substantial component of which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has been used for providing pain relief following abdominal surgery. We designed this study with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic cholecystectomy provides superior analgesic effects than port-side infiltration.

Detailed Description

In this randomized and double-blind study, 75 patients, American Society of Anesthesiology (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic cholecystectomy operation under general anesthesia will be accepted. The patients will be divided into three groups and they will be given postoperative pain treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24, Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12, 16 and 24.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-10
• Primary Completion: 2015-07
• Study Completion: 2016-08
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• ASA I-II risk group,
• between the ages of 20-60,
• undergo elective laporoscopic cholecystectomy operation under general anesthesia

Exclusion Criteria

• allergy to anesthetic medication,
• coronary artery patients,
• obese patients,
• emergencies,
• pregnants,
• abdomen operation history
• heart block

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TAP	Levobupivacaine 0.25 %	Group T (n=25) will be given bilateral total 30 ml 0.25 % levobupivacaine administering TAP block under the guidance of ultrasound at the preoperative period.
local infiltration	Levobupivacaine 0.5%	Group L (n=25) will be given total 30 ml 0.25 % levobupivacaine infiltration around trocar-site with injector in sterilized conditions without administering TAP block at the end of the operation

Primary Outcome Measures

Name	Time	Method
postoperative pain scores	24 hours	VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,

Secondary Outcome Measures

Name	Time	Method
postoperative total analgesic consumption	Postoperatively 24 h

Trial Locations

Locations (1)

Duzce University Medical Faculty; 🇹🇷 Duzce, Turkey