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

NCT ID: NCT02838719

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

INFERTILITY

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Perineural group

Group 1: perineural dexamethasone acetate added to bilateral transverse abdominis plane block with levobupivacaine

Group Type: EXPERIMENTAL

Perineural Dexamethasone acetate

Intervention Type: DRUG

Intravenous group

Group 2: Intravenous dexamethasone acetate added with bilateral transverse abdominal plane block with levobupivacaine

Group Type: ACTIVE_COMPARATOR

Intravenous dexamethasone acetate

Intervention Type: DRUG

Interventions

Perineural Dexamethasone acetate

Intervention Type: DRUG

Intravenous dexamethasone acetate

Intervention Type: DRUG

Other Intervention Names

Decoin; Decoin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Vetriselvan p

Junior Resident Anaesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PAIN86

Identifier Type: -

Identifier Source: org_study_id