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

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

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.

Study Overview

• Status: Completed
• Conditions: INFERTILITY
• Intervention / Treatment: Drug: Perineural Dexamethasone acetate; Drug: Intravenous dexamethasone acetate

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Perineural group; Group 1: perineural dexamethasone acetate added to bilateral transverse abdominis plane block with levobupivacaine	Drug: Perineural Dexamethasone acetate; Other Names: Decoin
ACTIVE_COMPARATOR: Intravenous group; Group 2: Intravenous dexamethasone acetate added with bilateral transverse abdominal plane block with levobupivacaine	Drug: Intravenous dexamethasone acetate; Other Names: Decoin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: July 16, 2016
• First Posted (ESTIMATE): July 20, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 16, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: PAIN86

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO