Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cholecystectomy, Laparoscopic, Pain, Postoperative

Intervention / Treatment
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* Drug: Levobupivacaine 0.25 %
* Drug: Levobupivacaine 0.5%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: local infiltration<br>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 | Drug: Levobupivacaine 0.5%<br> <br> * Other names: chirocaine;|
| No Intervention: Control<br>Only routine general anesthesia will be applied | |
| Experimental: TAP<br>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. | Drug: Levobupivacaine 0.25 %<br> <br> * Other names: chirocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain scores | VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h, | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative total analgesic consumption |  | Postoperatively 24 h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levobupivacaine, Transversus abdominis plane block