The Efficacy of Regional Scalp Block in Craniotomy

NCT06720285 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: IRB: 0769/KEPK/IX/2023INA-XOYLZRE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Scalp Nerve Block; Craniotomy Surgery

Keywords

Regional anesthesia; Scalp Nerve Block; Craniotomy; Surgery

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

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

  From enrollment until 24 hours post craniotomy surgery.

Secondary Outcomes (3)

• Pain Scale

  0 to 24 hours after surgery

• Laboratory Markers

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

• The patients with PONV

  0 to 24 hour after surgery

Study Arms (2)

Standard Treatment with Scalp Nerve Block

EXPERIMENTAL

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.

Procedure: nerve block with 0.5% ropivacaine; Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium)

Standard Treatment

ACTIVE COMPARATOR

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.

Drug: General anesthesia and opioids (fentanyl, propofol, rocuronium)

Interventions

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.

Standard Treatment with Scalp Nerve Block

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.

Standard Treatment; Standard Treatment with Scalp Nerve Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Universitas Airlangga: lead
• Dr. Soetomo Hospital, Surabaya: collaborator
• Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia: collaborator

Study Sites (1)

Dr. Soetomo Hospital, Surabaya

Surabaya, East Java, Indonesia

Location

Related Publications (6)

• Chen Y, Ni J, Li X, Zhou J, Chen G. Scalp block for postoperative pain after craniotomy: A meta-analysis of randomized control trials. Front Surg. 2022 Sep 26;9:1018511. doi: 10.3389/fsurg.2022.1018511. eCollection 2022.

  PMID: 36225222 BACKGROUND

• Costello TG, Cormack JR. Anaesthesia for awake craniotomy: a modern approach. J Clin Neurosci. 2004 Jan;11(1):16-9. doi: 10.1016/j.jocn.2003.09.003. No abstract available.

  PMID: 14642359 BACKGROUND

• Benyahia NM, Verster A, Saldien V, Breebaart M, Sermeus L, Vercauteren M. Regional anaesthesia and postoperative analgesia techniques for spine surgery - a review. Rom J Anaesth Intensive Care. 2015 Apr;22(1):25-33.

  PMID: 28913452 BACKGROUND

• Vadivelu N, Kai AM, Tran D, Kodumudi G, Legler A, Ayrian E. Options for perioperative pain management in neurosurgery. J Pain Res. 2016 Feb 10;9:37-47. doi: 10.2147/JPR.S85782. eCollection 2016.

  PMID: 26929661 BACKGROUND

• Ghai B, Jafra A, Bhatia N, Chanana N, Bansal D, Mehta V. Opioid sparing strategies for perioperative pain management other than regional anaesthesia: A narrative review. J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):3-10. doi: 10.4103/joacp.JOACP_362_19. Epub 2022 Feb 4.

  PMID: 35706649 BACKGROUND

• Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. doi: 10.3171/jns.2007.106.2.210.

  PMID: 17410701 BACKGROUND

MeSH Terms

Interventions

Nerve Block; Ropivacaine; Anesthesia, General; Analgesics, Opioid; Fentanyl; Propofol; Rocuronium

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Christijogo Soemartono Waloejo, MD, Ph.D

  Anesthesiology and Reanimation Department, Dr. Soetomo General Hospital, Universitas Airlangga, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: October 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

ID (1)