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The Efficacy of Regional Scalp Block in Craniotomy

NCT06720285 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-06

No results posted yet for this study

Summary

The objective of this clinical trial is to evaluate the role of scalp nerve block in craniotomy. The primary questions it seeks to answer are: What are the efficacy and safety profiles of scalp nerve block in craniotomy? The anesthesia protocol and monitoring were standardized for all participants. Participants were divided into two groups: the scalp nerve block group and the general anesthesia group. General anesthesia was induced using fentanyl (1-2 mcg/kg), propofol (1-2 mg/kg), and rocuronium (0.6 mg/kg). In the scalp nerve block group, a nerve block was administered using 0.5% ropivacaine.

Conditions

  • Scalp Nerve Block
  • Craniotomy 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.

Sponsors & Collaborators

  • Dr. Soetomo Hospital, Surabaya

    collaborator UNKNOWN

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

    collaborator OTHER_GOV

  • Universitas Airlangga

    lead OTHER

Principal Investigators

  • Christijogo Soemartono Waloejo, MD, Ph.D · Anesthesiology and Reanimation Department, Dr. Soetomo General Hospital, Universitas Airlangga, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06720285 on ClinicalTrials.gov