OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients (OSTAP/TAP)
Primary Purpose
Pain Postoperative
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TAP
OSTAP
Sponsored by
About this trial
This is an interventional other trial for Pain Postoperative focused on measuring TAP OSTAP Postoperative pain
Eligibility Criteria
Inclusion Criteria:
- Scheduled for laparoscopic cholecystectomy
- ASA status I-II
Exclusion Criteria:
- Local anesthetic allergy
- Coagulopathy
- Infection at procedure site
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Group 1: TAP Block
Group 2: OSTAP Block
No Block
Arm Description
TAP Block performed from the petit triangle ( 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.
No interventions
Outcomes
Primary Outcome Measures
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.
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
Amount of total intraoperative remifentanil infusion
The total amount of infused remifentanil throughout the surgery will be recorded from the infusion device.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03954795
Brief Title
OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balikesir University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Postoperative
Keywords
TAP OSTAP Postoperative pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: TAP Block
Arm Type
Active Comparator
Arm Description
TAP Block performed from the petit triangle ( anterior axillary line and iliac crest.)
Arm Title
Group 2: OSTAP Block
Arm Type
Active Comparator
Arm Description
Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.
Arm Title
No Block
Arm Type
No Intervention
Arm Description
No interventions
Intervention Type
Procedure
Intervention Name(s)
TAP
Intervention Description
Classic TAP block performed through the petit triangle (the anterior axillary line and iliac crest)
Intervention Type
Procedure
Intervention Name(s)
OSTAP
Intervention Description
Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.
Primary Outcome Measure Information:
Title
Change in postoperative pain scores throughout time evaluated by VAS
Description
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.
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.
Title
Change in opioid Sparing effect measured through morphine amount delivered by a patient controlled analgesia device.
Description
The amount of morphine demand of the patient measured through morphine delivery by the 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.
Title
Amount of total intraoperative remifentanil infusion
Description
The total amount of infused remifentanil throughout the surgery will be recorded from the infusion device.
Time Frame
At the end of surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled for laparoscopic cholecystectomy
ASA status I-II
Exclusion Criteria:
Local anesthetic allergy
Coagulopathy
Infection at procedure site
12. IPD Sharing Statement
Learn more about this trial
OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients
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