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

Not Applicable

Completed

• Conditions: INFERTILITY
• Interventions: Drug: Perineural Dexamethasone acetate; Drug: Intravenous dexamethasone acetate

• Registration Number: NCT02838719
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-05-26
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-16
• Last Update Submitted: 2016-07-16
• Study First Posted: 2016-07-20
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perineural group	Perineural Dexamethasone acetate	Group 1: perineural dexamethasone acetate added to bilateral transverse abdominis plane block with levobupivacaine
Intravenous group	Intravenous dexamethasone acetate	Group 2: Intravenous dexamethasone acetate added with bilateral transverse abdominal plane block with levobupivacaine

Primary Outcome Measures

Name	Time	Method
Time to first rescue analgesic	first 24 hours	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

Name	Time	Method
Total amount of rescue analgesic required in 1st 24 hours postoperatively	0, 0.25, 0.50, 0.75, 1 , 2, 4, 6, 8,12, 24 hours	Pain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given.