A study to compare the pain relief and other associated effects during surgery and in the immediate post-operative period of a local anaesthetic drug ropivacaine alone and along with a steroid (which prolongs the drug effect) injected into the scalp, in patients undergoing brain surgery

Completed

• Conditions: Disorder of brain, unspecified, Supratentorial space-occupying lesions in the brain,

• Registration Number: CTRI/2014/06/004688
• Lead Sponsor: Fluid Research Grant Christian Medical College and Hospital Vellore

Brief Summary

This is a double blinded randomized control trial studying the effect of adding dexamethasone (a steroid) as an adjuvant to scalp nerve blocks with local anaesthetic 0.2% ropivacaine, in patients undergoing supratentorial craniotomy under general anaesthesia. One group of patients received 8 mg (2 ml) of dexamethasone along with the local anaesthetic in the scalp nerve block and the other group received 2 ml of normal saline. The study drug (dexamethasone or saline) was blinded to the patient, prinicipal investigator and outcome assessor. The primary outcome assessed was the duration of post-operative analgesia afforded by addition of dexamethasone to the scalp nerve block. This was defined as the time from administration of the scalp nerve block up to the time to first rescue analgesic post-operatively. They secondary outcomes assessed include a comparison of the intra-operative anaesthetic requirements (measured by the intra-operative used of opioid fentanyl and induction agent propofol), the time to emergence from general anaesthesia as well as incidence of post-op nausea and vomiting between the  two groups. Both groups of patients were followed up for 24 hours after the surgery to assess the primary and secondary outcomes. Presently. 100 patients have been recruited of which 90 patients have been allocated to the 2 groups: 45 in each arm. The interim analysis is underway.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-03
• Study Completion: 2015-08-12
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

American Society of Anaesthesiology Class I to III Supratentorial intra-cranial space-occupying lesions Pre-op GCS 15/15.

Exclusion Criteria

1.Patients who have undergone previous craniotomy 2.Hypertensive patients on beta blockers 3.Patients diagnosed with diabetes mellitus 4.Pre-operative Glasgow Coma Scale (GCS) less than 15 5.Pregnant patients 6.Patients with known allergy to local anaesthetics 7.Patients with peptic ulcer disease 8.Patients with coagulopathy 9.Patients with scalp infection 10.Patients who refused to give consent to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To compare duration of post-operative analgesia afforded by addition of dexamethasone as adjuvant to local anaesthetic ropivacaine in scalp nerve blocks with plain ropivacaine in patients undergoing supratentorial craniotomy	Post-op pain was assessed using Visual Analogue Scale (VAS) score at zero hours, 4 hours, 8 hours, 12 hours and 24 hours post-op. The time when the first dose of post-op rescue analgesic was given was noted. The total duration of analgesia was computed from the time of administration of the scalp nerve block till the time of first post-op rescue analgesic.

Secondary Outcome Measures

Name	Time	Method
To evaluate the following parameters in the patients who receive plain ropivacaine in the scalp nerve block and those who receive ropivacaine as well as dexamethasone in the scalp block:	-intra-operative anaesthetic requirement

Trial Locations

Locations (1)

Chrsitian Medical College and Hospital, Vellore; 🇮🇳 Vellore, TAMIL NADU, India

Chrsitian Medical College and Hospital, Vellore

🇮🇳Vellore, TAMIL NADU, India

Riya Jose

Principal investigator

9486170456

riyamithun@gmail.com