Overview

This trial is active, not recruiting.

Conditions cholecystectomy, laparoscopic, pain, postoperative
Treatments levobupivacaine 0.25 %, levobupivacaine 0.5%
Phase phase 4
Sponsor Duzce University
Start date January 2014
End date July 2015
Trial size 75 participants
Trial identifier NCT02185716, 2013-414

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 surgeries. We designed this study with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic cholecystectomy provides superior analgesic effects than port-side infiltration.

In this randomized and double-blind study, 75 patients who are in American Society of Anesthesiology (ASA) I-II risk group, between the ages of 20-60, and 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,VAS I (superficial pain), VAS II (deep pain), postoperative total analgesic proportion, nausea, and vomiting will be recorded under 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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
levobupivacaine 0.5% chirocaine
(No Intervention)
Only routine general anesthesia will be applied
(Experimental)
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.
levobupivacaine 0.25 % chirocaine

Primary Outcomes

Measure
postoperative pain scores
time frame: 24 hours

Secondary Outcomes

Measure
postoperative total analgesic consumption
time frame: Postoperatively 24 h

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title Comparison Of Ultrasound Guided Transversus Abdominis Plane Block (TAP) and Local Infiltration Analgesia During Laparoscopic Cholecystectomy Surgery
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Duzce University.