A study on dexmethasone as an adjuvant to 0.2% Ropivacaine in USG guided preemptive caudal epidural block for peri operative analgesia in patients undergoing lumbar spine surgeries

Phase 2/3

Not yet recruiting

• Conditions: Administration, (2) ICD-10 Condition: 3||Administration, (3) ICD-10 Condition: 3||Administration,

• Registration Number: CTRI/2022/09/045813
• Lead Sponsor: Dr Sitara A Y

Brief Summary

This study is a randomized, double blind, parallel group, trial comparing the safety and efficacy of Ropivacaine 0.2% and Ropivacaine 0.2% with Inj Dexamethasone 8mg in 50 patients undergoing lumbar spine surgery that will be conducted in Vydehi medical college and research centre in India. The primary outcome measures will be opioid consumption between the 2 groups and Duration and efficacy of analgesia between the group. The secondary outcomes will be hemodynamic changes in the peri operative period between the group and adverse effects like nausea, vomiting, dowsiness, sedation in post operative period between the two group.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-09
• Study Start: 2022-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Patients belonging to ASA I,II.
• Patients who give informed written consent.

Exclusion Criteria

• 1.Patients refusal for study, patients who underwent a previous lumbar spine surgery 2.
• Patients with a contraindication to regional anaesthesia 3.
• Patients with hypersensitivity to ropivacaine.
• Patients with known cardiac, renal, hepatic, neurological disorders that would interfere with cardiovascular response assessment.
• Patients with spine abnormalities and body dysmorphism.
• Patients with coagulopathy or on any anti coagulants.
• Use of benzodiazepines, anticonvulsants, alcohol, opioids or other psychotropic drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare intraoperative opioid consumption	6-48hrs
To compare duration of analgesia	6-48hrs

Secondary Outcome Measures

Name	Time	Method
To compare the hemodynamic changes	To compare adverse effects

Trial Locations

Locations (1)

Vydehi institute of medical sciences and research centre; 🇮🇳 Bangalore, KARNATAKA, India

Vydehi institute of medical sciences and research centre

🇮🇳Bangalore, KARNATAKA, India

Dr Sitara

Principal investigator

9902096666

drsitaraay@gmail.com