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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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INFERTILITY

Intervention / Treatment
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* Drug: Perineural Dexamethasone acetate
* Drug: Intravenous dexamethasone acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perineural group<br>Group 1: perineural dexamethasone acetate added to bilateral transverse abdominis plane block with levobupivacaine | Drug: Perineural Dexamethasone acetate<br> <br> * Other names: Decoin;|
| Active Comparator: Intravenous group<br>Group 2: Intravenous dexamethasone acetate added with bilateral transverse abdominal plane block with levobupivacaine | Drug: Intravenous dexamethasone acetate<br> <br> * Other names: Decoin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0, 0.25, 0.50, 0.75, 1 , 2, 4, 6, 8,12, 24 hours |