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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
Balikesir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain Postoperative focused on measuring TAP OSTAP Postoperative pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 14, 2019
    Last Updated
    May 17, 2019
    Sponsor
    Balikesir University
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    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

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    OSTAP Versus TAP for Postoperative Pain Management in Laparoscopic Cholecystectomy Patients

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