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Completed

NCT Number: NCT02838719

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perineural Dexamethasone acetate

Drug

Other names: Decoin

Intravenous dexamethasone acetate

Drug

Other names: Decoin

Primary outcomes

  1. Time to first rescue analgesic

    Time frame: 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 outcomes

  1. Total amount of rescue analgesic required in 1st 24 hours postoperatively

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study 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

Acronym: AEDDATB

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2016
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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