OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients
OSTAP/TAP
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
1 other identifier
interventional
75
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 14, 2019
CompletedFirst Posted
Study publicly available on registry
May 17, 2019
CompletedMay 21, 2019
May 1, 2019
1.7 years
May 14, 2019
May 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Study Arms (3)
Group 1: TAP Block
ACTIVE COMPARATORTAP Block performed from the petit triangle ( anterior axillary line and iliac crest.)
Group 2: OSTAP Block
ACTIVE COMPARATORModified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.
No Block
NO INTERVENTIONNo interventions
Interventions
Classic TAP block performed through the petit triangle (the anterior axillary line and iliac crest)
Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.
Eligibility Criteria
You may qualify if:
- Scheduled for laparoscopic cholecystectomy
- ASA status I-II
You may not qualify if:
- Local anesthetic allergy
- Coagulopathy
- Infection at procedure site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associated professor
Study Record Dates
First Submitted
May 14, 2019
First Posted
May 17, 2019
Study Start
September 1, 2014
Primary Completion
May 1, 2016
Study Completion
August 1, 2016
Last Updated
May 21, 2019
Record last verified: 2019-05