OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients

Pain Postoperative Clinical Trial

— OSTAP/TAP  

Official title:

The Comparison of Analgesic Sparing Effects of Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) and Transversus Abdominis Plane Block (TAP) in Patients Undergoing Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954795
• Other study ID #: BAUA
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: August 2016

Study information

• Verified date: May 2019
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Scheduled for laparoscopic cholecystectomy

• ASA status I-II

Exclusion Criteria:

• Local anesthetic allergy

• Coagulopathy

• Infection at procedure site

Related Conditions & MeSH terms

• Pain Postoperative
• Pain, Postoperative

Intervention

Procedure:
• TAP
Classic TAP block performed through the petit triangle (the anterior axillary line and iliac crest)
• OSTAP
Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in postoperative pain scores throughout time evaluated by VAS	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.	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.
Primary	Change in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.	The amount of morphine demand of the patient measured through morphine delivery by the 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.
Primary	Amount of total intraoperative remifentanil infusion	The total amount of infused remifentanil throughout the surgery will be recorded from the infusion device.	At the end of surgery.