Clinical trial NCT02185716: Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery
Official title: Comparison Of Ultrasound Guided Transversus Abdominis Plane Block (TAP) and Local Infiltration Analgesia During Laparoscopic Cholecystectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholecystectomy, Laparoscopic
Pain, Postoperative
Keywords: Transversus abdominis plane block
levobupivacaine
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2014-07-10
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: postoperative pain scores
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative total analgesic consumption
timeFrame: Postoperatively 24 h
Other outcomes:
measure: side effects
timeFrame: postoperatively 24 h
Locations:
city: Duzce
country: Turkey
facility: Duzce University Medical Faculty
Study officials:
affiliation: Duzce University
name: Gülbin Sezen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wassef M, Lee DY, Levine JL, Ross RE, Guend H, Vandepitte C, Hadzic A, Teixeira J. Feasibility and analgesic efficacy of the transversus abdominis plane block after single-port laparoscopy in patients having bariatric surgery. J Pain Res. 2013 Nov 27;6:837-41. doi: 10.2147/JPR.S50561. eCollection 2013.
citation: Keir A, Rhodes L, Kayal A, Khan OA. Does a transversus abdominis plane (TAP) local anaesthetic block improve pain control in patients undergoing laparoscopic cholecystectomy? A best evidence topic. Int J Surg. 2013;11(9):792-4. doi: 10.1016/j.ijsu.2013.05.039. Epub 2013 Jun 11.