The Efficacy of Regional Scalp Block in Craniotomy

Early Phase 1CompletedNCT06720285

Universitas Airlangga40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Scalp Nerve Block Craniotomy Surgery

Interventions

nerve block with 0.5% ropivacainePROCEDURE

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.

General anesthesia and opioids (fentanyl, propofol, rocuronium)DRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr. Soetomo Hospital, Surabaya

Surabaya, East Java, Indonesia

Outcomes

Primary Outcomes

Total opioid consumption

Opioid used was fentanyl, and it was administered during and post surgery which was measured μg/kg.

Time frame: From enrollment until 24 hours post craniotomy surgery.

Secondary Outcomes

Pain Scale

Pain scale was assessed using the Critical-care Pain Observational Tool (CPOT) every 4 hours

Time frame: 0 to 24 hours after surgery

Laboratory Markers

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).

Time frame: After induction of anesthesia, 6 hours after incision, and 24 hours after surgery.

The patients with PONV

Postoperative nausea and vomiting

Time frame: 0 to 24 hour after surgery

Data from ClinicalTrials.gov

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