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Completed

NCT Number: NCT06720285

The Efficacy of Regional Scalp Block in Craniotomy

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.

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Key information

Conditions

Scalp Nerve Block Craniotomy Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dr. Soetomo Hospital, Surabaya

Surabaya, East Java, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nerve block with 0.5% ropivacaine

Procedure

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.

Primary outcomes

  1. Total opioid consumption

    Time frame: 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 outcomes

  1. Pain Scale

    Time frame: 0 to 24 hours after surgery

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

  2. Laboratory Markers

    Time frame: 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).

  3. The patients with PONV

    Time frame: 0 to 24 hour after surgery

    Postoperative nausea and vomiting

Sponsors and collaborators

Lead sponsor

Universitas Airlangga

Other

Collaborators

  • Dr. Soetomo Hospital, Surabaya
  • Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Registry information

Official study title

The Efficacy of Regional Scalp Block Local Anesthesia as Preemptive Analgesia in Craniotomy Surgery

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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