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OpenTrials
Completed

NCT Number: NCT03954795

OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients

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

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Key information

Conditions

Pain Postoperative Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scheduled for laparoscopic cholecystectomy
  • ASA status I-II

Exclusion criteria

  • Local anesthetic allergy
  • Coagulopathy
  • Infection at procedure site

Treatment and study plan

TAP

Procedure

Classic TAP block performed through the petit triangle (the anterior axillary line and iliac crest)

ostap

Procedure

Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.

Primary outcomes

  1. Change in postoperative pain scores throughout time evaluated by VAS

    Time frame: 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.

  2. Change in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.

    Time frame: 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

  3. Amount of total intraoperative remifentanil infusion

    Time frame: At the end of surgery.

    The total amount of infused remifentanil throughout the surgery will be recorded from the infusion device.

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Official study 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

Acronym: OSTAP/TAP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 17, 2019
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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