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
About this trial
This is an interventional supportive care trial for INFERTILITY
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
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
NCT ID
NCT02838719
First Posted
May 26, 2016
Last Updated
July 16, 2016
Sponsor
Postgraduate Institute of Medical Education and Research
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
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Analgesic Efficacy of Dexamethasone in Different Routes of Administration in Transverse Abdominis Plane Block
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