The Efficacy of Regional Scalp Block in Craniotomy

Early Phase 1

Completed

• Conditions: Scalp Nerve Block; Craniotomy Surgery
• Interventions: Procedure: nerve block with 0.5% ropivacaine; Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium)

• Registration Number: NCT06720285
• Lead Sponsor: Universitas Airlangga

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged >18 years
• American Society of Anesthesiologists (ASA) classification I-III
• Glasgow Coma Scale (GCS) score ≥ 13
• Elective craniotomy

Exclusion Criteria

• Patients with cardiovascular abnormalities, impaired renal and hepatic function, diabetes mellitus, systemic and/or scalp local infection, and those with a history of current dexamethasone administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment with Scalp Nerve Block	nerve block with 0.5% ropivacaine	General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Subsequently, scalp nerve block was performed with 0.5% ropivacaine. During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia.
Standard Treatment with Scalp Nerve Block	General anesthesia and opioids (fentanyl, propofol, rocuronium)	General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Subsequently, scalp nerve block was performed with 0.5% ropivacaine. During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia.
Standard Treatment	General anesthesia and opioids (fentanyl, propofol, rocuronium)	General anesthesia induction was performed by administering fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Then, continuous fentanyl infusion as analgesia maintenance as the standard treatment. During surgery, a sudden rise of heart rate and blood pressure higher than 20% from baseline was considered as pain, and a bolus of fentanyl was administered as rescue analgesia.

Primary Outcome Measures

Name	Time	Method
Total opioid consumption	From enrollment until 24 hours post craniotomy surgery.	Opioid used was fentanyl, and it was administered during and post surgery which was measured μg/kg.

Secondary Outcome Measures

Name	Time	Method
Pain Scale	0 to 24 hours after surgery	Pain scale was assessed using the Critical-care Pain Observational Tool (CPOT) every 4 hours
The patients with PONV	0 to 24 hour after surgery	Postoperative nausea and vomiting
Laboratory Markers	After induction of anesthesia, 6 hours after incision, and 24 hours after surgery.	Laboratory markers measured were Interleukin (IL)-6 (pg/mL), Tumor Necrosis Factor (TNF)-α (pg/mL), prostaglandin E2 (PGE2) (pg/mL), cortisol level (μg/dL), blood glucose level (mg/dL), neutrophil count (cells/μL), lymphocyte count (cells/μL) and neutrophil-to-lymphocyte ratio (NLR).

Trial Locations

Locations (1)

Dr. Soetomo Hospital, Surabaya; 🇮🇩 Surabaya, Jawa Timur, Indonesia