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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

A RANDOMIZED CONTROL TRIAL TO COMPARE THE EFFECT OF SCALP BLOCK USING ROPIVACAINE ALONE OR ROPIVACAINE ALONG WITH ADJUVANT DEXAMETHASONE IN PATIENTS UNDERGOING SUPRATENTORIAL CRANIOTOMY UNDER GENERAL ANAESTHESIA (G.A.)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/06/004688
Enrollment
162
Registered
2014-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G939- Disorder of brain, unspecified Health Condition 2: null- Supratentorial space-occupying lesions in the brain

Interventions

Intervention1: Dexamethasone 8 mg: 8 mg (2 ml) of dexamethasone added to 30 ml of 0.2% ropivacaine given subcutaneously as a single dose in the scalp nerve block in the study arm. Control Intervention

Sponsors

Fluid Research Grant Christian Medical College and Hospital Vellore
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 - time to emergence from general anaesthesia - incidence of post-operative nausea and vomiting Timepoint: up to 24 hours after surgery—

Countries

India

Contacts

Public ContactRiya Jose

Christian Medical College and Hospital Vellore

grace.korula@gmail.com9952121136

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026