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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Diskapi Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Procedure: Unilateral ESP Block; USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture; Drug: 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.
ACTIVE_COMPARATOR: 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.	Drug: 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.; Procedure: Unilateral OSTAP Block; USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture
ACTIVE_COMPARATOR: 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.	Drug: 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.; Procedure: Injection of Local Anesthetic to Trocar Insertion; Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.
SHAM_COMPARATOR: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nause and vomiting	The patient with nausea and vomiting will be recorded.	24 hours

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (ACTUAL): October 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No