OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients

Not Applicable

Completed

• Conditions: Pain Postoperative
• Interventions: Procedure: OSTAP; Procedure: TAP

• Registration Number: NCT03954795
• Lead Sponsor: Balikesir University

Brief Summary

The aim of the study is to compare the effectiveness and opioid sparing effects of TAP and OSTAP in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Patients undergoing laparoscopic cholecystectomy were separated into 3 groups. Group 1: Received TAP block Group 2: Received OSTAP Group 3: No Block Standard General Anesthesia was induced and maintained in all patients. At the end of the operation patient controlled analgesia with morphine was applied to all patients.

Pain scores were evaluated at 0,2,4,6,12,24 hours postoperatively. Total morphine consumption and pain scores were compared.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-05
• Study Completion: 2016-08
• Status Verified: 2019-05
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Scheduled for laparoscopic cholecystectomy
• ASA status I-II

Exclusion Criteria

• Local anesthetic allergy
• Coagulopathy
• Infection at procedure site

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: OSTAP Block	OSTAP	Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.
Group 1: TAP Block	TAP	TAP Block performed from the petit triangle ( anterior axillary line and iliac crest.)

Primary Outcome Measures

Name	Time	Method
Change in postoperative pain scores throughout time evaluated by VAS	Pain scores will be recorded for 24 hours postoperatively. The first measure will be taken immediately after surgery (time 0) and then at 2. 4. 6. 12. 24. hours.	Pain scores are going to be evaluated via VAS score. The VAS score will be scored between 0-10. 0 points is defined as no pain and 10 points is the most severe pain imaginable by the patient. A higher VAS score reflects a poor pain control.
Change in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.	The amount of Morphine demanded by the patient will be recorded for 24 hours postoperatively. The first measure will be taken immediately after surgery (time 0) and then at 2. 4. 6. 12. 24. hours.	The amount of morphine demand of the patient measured through morphine delivery by the patient controlled analgesia device
Amount of total intraoperative remifentanil infusion	At the end of surgery.	The total amount of infused remifentanil throughout the surgery will be recorded from the infusion device.