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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-10

Study Completion Date

2019-05-30

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

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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.

Conditions

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Biliary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective randomised

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

patients and outcome assesors will be blinded for the analgesia method

Study Groups

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Transversus abdominis plane block

will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

Group Type EXPERIMENTAL

Transversus abdominis plane block

Intervention Type DRUG

will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

Intravenous patient controlled analgesia

Intervention Type DRUG

will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia

Local infiltration anesthesia

will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia

Group Type ACTIVE_COMPARATOR

local infiltration anesthesia

Intervention Type DRUG

will receive 20ml bupivacaine for local infiltration anesthesia and intravenous patient controlled analgesia

Intravenous patient controlled analgesia

Intervention Type DRUG

will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia

Intravenous patient control analgesia

will not receive any regional anethetic intervention will receive intravenous patient controlled analgesia

Group Type SHAM_COMPARATOR

Intravenous patient controlled analgesia

Intervention Type DRUG

will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia

Interventions

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Transversus abdominis plane block

will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

Intervention Type DRUG

local infiltration anesthesia

will receive 20ml bupivacaine for local infiltration anesthesia and intravenous patient controlled analgesia

Intervention Type DRUG

Intravenous patient controlled analgesia

will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No