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
Not Applicable
Completed
- Conditions
- Health Condition 1: G939- Disorder of brain, unspecifiedHealth Condition 2: null- 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
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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 craniotomyTimepoint: 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: <br/ ><br>-intra-operative anaesthetic requirement <br/ ><br>-time to emergence from general anaesthesia <br/ ><br>-incidence of post-operative nausea and vomiting <br/ ><br>Timepoint: up to 24 hours after surgery