Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

Duzce University

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative; Cholecystectomy, Laparoscopic

Treatments: Drug: Levobupivacaine 0.5%; Drug: Levobupivacaine 0.25 %

Study type: Interventional

Funder types: Other

Identifiers

NCT02185716

2013-414

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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75 participants in 3 patient groups

local infiltration

Active Comparator group

Description:

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

Treatment:

Drug: Levobupivacaine 0.5%

Control

No Intervention group

Description:

Only routine general anesthesia will be applied

TAP

Experimental group

Description:

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.

Treatment:

Drug: Levobupivacaine 0.25 %