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Clinical Trials/NCT02185716
NCT02185716
Completed
Phase 4

Comparison Of Ultrasound Guided Transversus Abdominis Plane Block (TAP) and Local Infiltration Analgesia During Laparoscopic Cholecystectomy Surgery

Duzce University1 site in 1 country75 target enrollmentJanuary 2014

Overview

Phase
Phase 4
Intervention
Levobupivacaine 0.5%
Conditions
Cholecystectomy, Laparoscopic
Sponsor
Duzce University
Enrollment
75
Locations
1
Primary Endpoint
postoperative pain scores
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
August 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Duzce University
Responsible Party
Principal Investigator
Principal Investigator

gulbin sezen

assistant of professor

Duzce University

Eligibility Criteria

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

Arms & Interventions

local infiltration

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

Intervention: Levobupivacaine 0.5%

TAP

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.

Intervention: Levobupivacaine 0.25 %

Outcomes

Primary Outcomes

postoperative pain scores

Time Frame: 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 Outcomes

  • postoperative total analgesic consumption(Postoperatively 24 h)

Study Sites (1)

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