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Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Pain, Laparoscopic Cholecystectomy, Regional Anesthesia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
M-TAPA block
EXORA block
Tramadol
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

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

Inclusion Criteria: laparoscopic cholecystectomy surgery Patients with ASA (American Society of Anaesthetists) scores I and III will be included. Exclusion Criteria: Uncontrolled Arterial Hypertension Uncontrolled Diabetes Mellitus, Mental retardation , Antidepressant use Metabolic disorders, Bleeding diathesis Patients with a body mass index above 30.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group M

    Group E

    Group P

    Arm Description

    ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block

    Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block

    Patient-controlled analgesia with tramadol

    Outcomes

    Primary Outcome Measures

    NRS
    The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    Secondary Outcome Measures

    tramadol consumption
    side effect profile scores
    1. Nausea and vomiting scale (nausea-vomiting scale (NVS): No nausea is present, Mild nausea is present. Severe nausea is present. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.
    additional analgesic use
    additional analgesic use
    pinprick test
    The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients. With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.
    Ramsay Sedation Scale
    Ramsay Sedation Scale (RSS) : Anxiety, agitation are present; Cooperated,awake; Sedated , response to commands; Sleepy, immediately awoken by auditory stimulus or glabella tap; Sleepy, deep response to auditory stimulus or glabella tap and Sleepy, no response to auditory stimulus or glabella tap )

    Full Information

    First Posted
    August 16, 2023
    Last Updated
    August 23, 2023
    Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06008002
    Brief Title
    Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy
    Official Title
    Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 25, 2023 (Anticipated)
    Primary Completion Date
    December 25, 2023 (Anticipated)
    Study Completion Date
    January 13, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bursa Yüksek İhtisas Education and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.
    Detailed Description
    In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Laparoscopic Cholecystectomy, Regional Anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective, single-blind, observational study
    Masking
    Outcomes Assessor
    Allocation
    Non-Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group M
    Arm Type
    Active Comparator
    Arm Description
    ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block
    Arm Title
    Group E
    Arm Type
    Active Comparator
    Arm Description
    Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block
    Arm Title
    Group P
    Arm Type
    Active Comparator
    Arm Description
    Patient-controlled analgesia with tramadol
    Intervention Type
    Procedure
    Intervention Name(s)
    M-TAPA block
    Intervention Description
    ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed
    Intervention Type
    Procedure
    Intervention Name(s)
    EXORA block
    Intervention Description
    Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol
    Intervention Description
    400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
    Primary Outcome Measure Information:
    Title
    NRS
    Description
    The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
    Time Frame
    Postoperative 24 hours
    Secondary Outcome Measure Information:
    Title
    tramadol consumption
    Time Frame
    Postoperative 24 hours
    Title
    side effect profile scores
    Description
    1. Nausea and vomiting scale (nausea-vomiting scale (NVS): No nausea is present, Mild nausea is present. Severe nausea is present. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.
    Time Frame
    Postoperative 24 hours
    Title
    additional analgesic use
    Description
    additional analgesic use
    Time Frame
    Postoperative 24 hours
    Title
    pinprick test
    Description
    The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients. With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.
    Time Frame
    Postoperative 24 hours
    Title
    Ramsay Sedation Scale
    Description
    Ramsay Sedation Scale (RSS) : Anxiety, agitation are present; Cooperated,awake; Sedated , response to commands; Sleepy, immediately awoken by auditory stimulus or glabella tap; Sleepy, deep response to auditory stimulus or glabella tap and Sleepy, no response to auditory stimulus or glabella tap )
    Time Frame
    Postoperative 24 hours

    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: laparoscopic cholecystectomy surgery Patients with ASA (American Society of Anaesthetists) scores I and III will be included. Exclusion Criteria: Uncontrolled Arterial Hypertension Uncontrolled Diabetes Mellitus, Mental retardation , Antidepressant use Metabolic disorders, Bleeding diathesis Patients with a body mass index above 30.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Korgün Ökmen, M.D
    Phone
    +905057081021
    Email
    korgunokmen@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Korgün Ökmen
    Organizational Affiliation
    University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy

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