Comparing the effect of a pain reducing agent(bupivacaine)adding another medicine(dexamethasone) which favours the action of bupivacaine versus bupivacaine alone, for pain relief injected near a nerve in the neck which is responsible for pain after a type of ear related surgery

Phase 2/3

Completed

• Conditions: Age group between 18 and 65years of either gender belonging to ASAPS 1 or 2undergoing Mastoid surgery

• Registration Number: CTRI/2018/02/011899
• Lead Sponsor: PG Thesis fund KMC Manipal

Brief Summary

The study is a prospective double blind randomised controlled study. It is a comparative evaluation of bupivacaine 0.25% with dexamethasone 2mg versus bupivacaine 0.25% alone in greater auricular nerve block for post-operative analgesia in mastoid surgery. Primary outcome is to measure the duration of analgesia in hours and secondary outcome is the requirement of rescue analgesics as per visual analogue scale of score 4 or more in the post-operative period.



conclusion - Dexamethasone as an adjuvant to bupivacaine in greater auricular nerve block significantly increases the duration of analgesia and reduces the need for rescue analgesics without any complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-24
• Study Completion: 2018-05-18
• Last Update Posted: 2018-08-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

ASAPS 1 or 2 undergoing Mastoid surgery.

Exclusion Criteria

Bleeding disorders On anticoagulant drugs Facial or other nerve palsy Infection,trauma, scar or sinuses at the site of block Known hypersensitivity to local anaesthetic drug Pregnant and lactating women Unable to speak or understand verbal command and VAS Unwilling to participate in the study Psychiatric illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
duration of analgesia	first 8 hours, hourly and then every 2 hours for 24 hours

Secondary Outcome Measures

Name	Time	Method
requirement of rescue analgesics	every hour for first 8 hours and every 2 hours for 24 hours till VAS 4 or more

Trial Locations

Locations (1)

Kasturba Medical College and Hospital; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Medical College and Hospital

🇮🇳Udupi, KARNATAKA, India

Dr Nandini D

Principal investigator

09986910818

nandini.nd@gmail.com