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

Not Applicable

Completed

• Conditions: Postoperative Pain; Regional Anesthesia
• Interventions: Procedure: Unilateral OSTAP Block; Procedure: Unilateral ESP Block; Procedure: Injection of Local Anesthetic to Trocar Insertion; Drug: intravenous patient controlled analgesia

• Registration Number: NCT03719157
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Study Start: 2019-04-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-10-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• ASA Status 1-2 patients 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Unilateral ESP Block	intravenous patient controlled analgesia	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.
Unilateral OSTAP block	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.
Unilateral ESP Block	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.
Unilateral OSTAP block	intravenous patient controlled analgesia	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.
Injection of Local Anesthetic to Trocar Insertion	intravenous patient controlled analgesia	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.
multimodal analgesia	intravenous patient controlled 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.
Injection of Local Anesthetic to Trocar Insertion	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.

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	24 hours	Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours.
Postoperative pain scores: NRS	24 hours	Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours.

Secondary Outcome Measures

Name	Time	Method
postoperative nause and vomiting	24 hours	The patient with nausea and vomiting will be recorded.

Trial Locations

Locations (1)

Diskapi education and research hospital; 🇹🇷 Ankara, Turkey