Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective 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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-10-01

Brief Summary

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Main purpose of this prospective single center randomized study is to compare the analgesic effect of ultrasound guided Unilateral Oblique Subcostal Transversus Abdominis Plane (TAP),unilateral Erector Spinae Plane (ESP) blocks and Port site infiltration of local anesthetic in subjects undergoing laparoscopic cholecystectomy. Total 100 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent laparoscopic cholecystectomy will recruit to the study.

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Detailed Description

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Conditions

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Postoperative Pain Regional Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unilateral ESP Block

Before general anaesthesia, Ultrasound guided unilateral ESP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.

Group Type ACTIVE_COMPARATOR

Unilateral ESP Block

Intervention Type PROCEDURE

USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture

intravenous patient controlled analgesia

Intervention Type DRUG

All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.

Unilateral OSTAP block

Under general anaesthesia, Ultrasound guided unilateral OSTAP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.

Group Type ACTIVE_COMPARATOR

Unilateral OSTAP Block

Intervention Type PROCEDURE

USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture

intravenous patient controlled analgesia

Intervention Type DRUG

All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.

Injection of Local Anesthetic to Trocar Insertion

After the laparoscopic surgery was completed, the trocar incision sites were closed. Following the infiltration rules, local anesthetic (15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine) was applied to the trocar sites of skin, fascia, muscle, and preperitoneal area by the surgical team after the operation. A total of 20 mL of local anesthetic was used, with 6 mL for trocar sites of 10 mm, and 4 mL for trocar sites of 5 mm .Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.

Group Type ACTIVE_COMPARATOR

Injection of Local Anesthetic to Trocar Insertion

Intervention Type PROCEDURE

Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.

intravenous patient controlled analgesia

Intervention Type DRUG

All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.

multimodal analgesia

Perioperative and postoperative routine analgesic protocol will be performed with no additional regional anesthesia method.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.

Group Type SHAM_COMPARATOR

intravenous patient controlled analgesia

Intervention Type DRUG

All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.

Interventions

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Unilateral ESP Block

USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture

Intervention Type PROCEDURE

Unilateral OSTAP Block

USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture

Intervention Type PROCEDURE

Injection of Local Anesthetic to Trocar Insertion

Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.

Intervention Type PROCEDURE

intravenous patient controlled analgesia

All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Patients with a body mass index (BMI) of \>40kg/m2
* ASA score of \>III
* Previous abdominal surgery
* Pregnant or breastfeeding patients
* Patients with coagulopathy
* Known local anesthetic allergy
* infection at the injection site

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No