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

INFERTILITY Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838719
• Other study ID #: PAIN86
• Status: Completed
• Phase: N/A
• First received: May 26, 2016
• Last updated: July 16, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• INFERTILITY

Intervention

Drug:
• Perineural Dexamethasone acetate

• Intravenous dexamethasone acetate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes