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Analgesic Efficacy of Dexamethasone in Different Routes of Administration in Transverse Abdominis Plane Block (AEDDATB)

Primary Purpose

INFERTILITY

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Perineural Dexamethasone acetate
Intravenous dexamethasone acetate
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for INFERTILITY

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women aged between 18 to 70 years undergoing gynaecological laparoscopic surgeries under general anaesthesia
  2. ASA physical status1 or 2

Exclusion Criteria:

  1. Local infection
  2. Morbid obesity (body mass index >35kg/m2)
  3. Allergy to local anaesthetics
  4. Patient refusal
  5. Severe respiratory or cardiac disorders
  6. Pre-existing neurological deficits
  7. Liver or renal insufficiency
  8. Preexisting diabetics
  9. Patient on steroid treatment for any reason.
  10. Peri Operative use of steroids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Perineural group

    Intravenous group

    Arm Description

    Group 1: perineural dexamethasone acetate added to bilateral transverse abdominis plane block with levobupivacaine

    Group 2: Intravenous dexamethasone acetate added with bilateral transverse abdominal plane block with levobupivacaine

    Outcomes

    Primary Outcome Measures

    Time to first rescue analgesic
    Pain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given. Duration between the end of anaesthesia to first analgesic requirement during first 24 hours of postoperative period.

    Secondary Outcome Measures

    Total amount of rescue analgesic required in 1st 24 hours postoperatively
    Pain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given.

    Full Information

    First Posted
    May 26, 2016
    Last Updated
    July 16, 2016
    Sponsor
    Postgraduate Institute of Medical Education and Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02838719
    Brief Title
    Analgesic Efficacy of Dexamethasone in Different Routes of Administration in Transverse Abdominis Plane Block
    Acronym
    AEDDATB
    Official Title
    Effect of Perineural Versus Intravenous Dexamethasone On Analgesic Efficacy of Transverse Abdominis Plane Block With Levobupivacaine In Laparoscopic Gynaecological Procedures: A Randomized, Double-Blind Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Postgraduate Institute of Medical Education and Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal wall. In the past, a number of adjuvants have been added to the local anaesthetics in peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to prolong the analgesia time. A number of previous studies have also shown an opioid sparing effect of steroids, when used intravenously perioperatively. Though previous studies have shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane block prolongs the duration of block, however it is not known whether this effect of dexamethasone is due to its peripheral action or because of its systemic absorption. Thus, in this study planned to compare the effectiveness of dexamethasone on quality and duration of analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane block versus when given systemically by intravenous route along with transverse abdominis plane block using local anaesthetics only, in patients undergoing gynaecological laparoscopic procedures under general anaesthesia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    INFERTILITY

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Perineural group
    Arm Type
    Experimental
    Arm Description
    Group 1: perineural dexamethasone acetate added to bilateral transverse abdominis plane block with levobupivacaine
    Arm Title
    Intravenous group
    Arm Type
    Active Comparator
    Arm Description
    Group 2: Intravenous dexamethasone acetate added with bilateral transverse abdominal plane block with levobupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    Perineural Dexamethasone acetate
    Other Intervention Name(s)
    Decoin
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous dexamethasone acetate
    Other Intervention Name(s)
    Decoin
    Primary Outcome Measure Information:
    Title
    Time to first rescue analgesic
    Description
    Pain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given. Duration between the end of anaesthesia to first analgesic requirement during first 24 hours of postoperative period.
    Time Frame
    first 24 hours
    Secondary Outcome Measure Information:
    Title
    Total amount of rescue analgesic required in 1st 24 hours postoperatively
    Description
    Pain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given.
    Time Frame
    0, 0.25, 0.50, 0.75, 1 , 2, 4, 6, 8,12, 24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women aged between 18 to 70 years undergoing gynaecological laparoscopic surgeries under general anaesthesia ASA physical status1 or 2 Exclusion Criteria: Local infection Morbid obesity (body mass index >35kg/m2) Allergy to local anaesthetics Patient refusal Severe respiratory or cardiac disorders Pre-existing neurological deficits Liver or renal insufficiency Preexisting diabetics Patient on steroid treatment for any reason. Peri Operative use of steroids

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Analgesic Efficacy of Dexamethasone in Different Routes of Administration in Transverse Abdominis Plane Block

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