Unilateral TAP Block vs Trocar Insertion Sites Infiltration Anesthesia in Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Laparoscopic cholecystectomy is a commonly performed operation in general surgery practice. Peripheral nerve block methods commonly used for analgesia after this operation are: transversus abdominis plane block (TAP) and trocar insertion sites local anesthetic infiltration anesthesia In this study, we aimed to compare these methods in terms of postoperative analgesia, nausea-vomiting and patient satisfaction

Detailed Description
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Patients will be randomly allocated by a computer generated random numbers list into three groups. After general anesthesia induction and intubation patients will receive analgesia according to group allocation. In group TAP (Group T) the transversus abdominis plane block will be commenced with ultrasound guidance while the patients is in the supine position with a subcostal approach using 20 mL 0.25% bupivacaine and 21 G block needle. In group infiltration anesthesia (Group I) the trocar insertion sites will be infiltrated with 20 mL 0.25% bupivacaine: 7 mL for the 10 mm trocar insertion sites and 3 mL for the 5 mm trocar insertion sites. The control group (Group C) will not receive any local anesthetic. All patients will receive rescue analgesia with intravenous patient controlled analgesia with tramadol (20 mg bolus dose and 20 minutes lockout time) Postoperative pain will be assessed during resting and coughing with a Numeric Pain Scale (NRS) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 3, 6, 12. and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.

Official Title
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Comparison of Postoperative Analgesia and Patient Satisfaction of Unilateral Transversus Abdominis Plane (TAP) Block and Trocar Site Infiltration Anesthesia in Laparoscopic Cholecystectomy

Conditions
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Biliary Disease

Intervention / Treatment
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* Drug: Transversus abdominis plane block
* Drug: local infiltration anesthesia
* Drug: Intravenous patient controlled analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Clinical diagnosis of biliary disease Exclusion Criteria: Uncooperative patients Blood coagulation disorders Laparatomy Obesity: body mass index >35 Renal failure Hepatic failure Emergency surgery Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomised
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transversus abdominis plane block<br>will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia | Drug: Transversus abdominis plane block<br>* will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia<br>Drug: Intravenous patient controlled analgesia<br>* will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia<br>|
| Active Comparator: Local infiltration anesthesia<br>will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia | Drug: local infiltration anesthesia<br>* will receive 20ml bupivacaine for local infiltration anesthesia and intravenous patient controlled analgesia<br>Drug: Intravenous patient controlled analgesia<br>* will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia<br>|
| Sham Comparator: Intravenous patient control analgesia<br>will not receive any regional anethetic intervention will receive intravenous patient controlled analgesia | Drug: Intravenous patient controlled analgesia<br>* will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia | Pain will be assessed with a 11 point numeric rating scale (0-10 whereas 0:no pain; 1-3: mild pain; 4-6: moderate pain and 7-10: severe pain) | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting (PONV) | PONV will be assessed with a 5 point PONV intensity scale (1-4 whereas 1:absence of PONV; 2: nausea present, vomiting absent; 3 nausea present, vomiting once; 4: nausea present vomiting twice or more | Postoperative 1st hour, 3rd hour, 6th hour, 12th hour and 24th hour | 
| Patient satisfaction | Satisfaction will be assessed with a 5 point Likert scale (0-4 whereas 0:definitely disagree; 1:slightly agree; 3: agree; 4: strongly agree) | Postoperative 24 th hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unilateral transversus abdominal plane block, Local infiltration anesthesia, Cholecystectomy, Postoperative analgesia