The Efficacy of Regional Scalp Block in Craniotomy

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 1, 2023

Primary Completion Date

November 30, 2023

Study Completion Date

November 30, 2023

Conditions
Scalp Nerve BlockCraniotomy Surgery
Interventions
PROCEDURE

nerve block with 0.5% ropivacaine

Compared to active comparator arm, the experimental arm received the same procedure except in the analgesia maintenance which was performed by nerve block of the scalp using 0.5% ropivacaine. However, during craniotomy surgery, pain may occur in patients in any arms. This was defined as a sudden rise of heart rate and blood pressure higher than 20% from baseline. In that case, a bolus of fentanyl was administered as rescue analgesia.

DRUG

General anesthesia and opioids (fentanyl, propofol, rocuronium)

Compared to experimental arm, the active comparator arm received the same procedure except in the analgesia maintenance which was performed through continuous fentanyl infusion. However, during craniotomy surgery, pain may occur in patients in any arms. This was defined as a sudden rise of heart rate and blood pressure higher than 20% from baseline. In that case, a bolus of fentanyl was administered as rescue analgesia.

Trial Locations (1)

Unknown

Dr. Soetomo Hospital, Surabaya, Surabaya

All Listed Sponsors
collaborator

Dr. Soetomo Hospital, Surabaya

UNKNOWN

collaborator

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

OTHER_GOV

lead

Universitas Airlangga

OTHER

NCT06720285 - The Efficacy of Regional Scalp Block in Craniotomy | Biotech Hunter | Biotech Hunter