A Comparative Analysis of Combined Superficial Cervical Plexus and Supraorbital Blocks Compared to Scalp Blocks During Craniotomy: a Review of Opioid Consumption and The Suppression of Hemodynamic Responses

NCT07131046 | Completed

• 1 other identifier: IndonesiaUAnes1002
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative pain management in craniotomy requires the administration of effective regional anesthetic techniques to reduce the use of systemic opioids and optimize hemodynamic control. Scalp block has been demonstrated to suppress hemodynamic response; however, its implementation generally involves a large number of injection points (six nerves that must be blocked bilaterally, resulting in a total of 12 injection points) and the possibility that not all nerve points are adequately blocked. Meanwhile, superficial cervical plexus and supraorbital block involves fewer injection points (two nerves to be blocked bilaterally, for a total of four injection points) with an analgesia area that may be sufficient to facilitate craniotomy surgery, including the insertion of Mayfield pins, consisting of only three pins, where the pin insertion area is not too large. The objective of this study is to compare the efficacy of combined superficial cervical plexus and supraorbital block with scalp block in reducing intraoperative opioid consumption and controlling hemodynamic response in craniotomy surgery.

Conditions

Craniotomy Surgery; Regional Anaesthesia; Scalp Block; Plexus Block;Analgesia;Neurosurgery

Keywords

superficial cervical plexus block; supraorbital nerve block; scalp block; craniotomy; remifentanil; regional anesthesia

Outcome Measures

Primary Outcomes (4)

• Remifentanil consumption for each step of surgery

  The target effect of the highest dose of Remifentanil administered by total controlled infusion when there is an increase in MAP or heart rate by more than 20% of the initial value for 30 seconds during Mayfield pin placement, skin incision, periosteal manipulation, and skin suturing.

  intraoperative

• The total amount of Remifentanil administered during the operation

  The total amount of remifentanil that the medical team used during the surgery

  Intraoperative

• The greatest alterations in mean arterial pressure (MAP) during the pinning procedure, followed by skin incision, periosteum manipulation, and skin suture.

  Changes in mean arterial pressure were measured at several points: 30 minutes after the block was administered; during pin insertion; during skin incision; during periosteal incision; and during skin suturing.

  Intraoperative

• The greatest alteration in heart rate during the pinning procedure, followed by skin incision, periosteum manipulation, and skin suture.

  Changes in heart rate were measured at several points: 30 minutes after the block was administered; during pin insertion; during skin incision; during periosteal incision; and during skin suturing.

  Intraoperative

Study Arms (2)

Combination of superficial cervical plexus block and supraorbital block

EXPERIMENTAL

Procedure: Combination of superficial cervical plexus block and supraorbital block

Scalp block

SHAM COMPARATOR

Procedure: Scalp block with bupivacaine alone

Interventions

Combination of superficial cervical plexus block and supraorbital block PROCEDURE

The combined anaesthesia technique involves the use of general anaesthesia and regional block in the superficial cervical plexus and supraorbital areas, with 6 ml of 0.25% bupivacaine injected into the superficial cervical plexus area and 2 ml into the supraorbital area.

Combination of superficial cervical plexus block and supraorbital block

Scalp block with bupivacaine alone PROCEDURE

A combination anaesthesia technique is used that involves general anaesthesia and scalp block. Scalp block using 0.25% bupivacaine in the supraorbital area (2 ml), supratrochlear (2 ml), zygomaticotemporal (2 ml), auriculotemporal (2 ml), major occipital (2 ml) and minor occipital (2 ml).

Scalp block

Eligibility Criteria

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

You may qualify if:

• The patient has been scheduled to undergo a craniotomy procedure that has been deemed medically necessary and electively scheduled. The aforementioned procedure will be performed under the administration of general anesthesia and the utilization of Mayfield pins.
• Adult patients who have reached an age of 18 years and have not yet reached 65 years of age are included in this study.
• Patients with ASA classification 1 - 3
• The patient has expressed their willingness to participate in a research study and has provided their signature on an informed consent form.

You may not qualify if:

• The patient has been diagnosed with an infection in the area where the block needle insertion is to be performed.
• The subjects of this study were patients with a body mass index (BMI) greater than 30 kg/m2 who were classified as Grade II obese.
• The patient is currently undergoing treatment with a beta-blocker.
• Patients in whom intraoperative evoked potential monitoring is scheduled.
• The patient is scheduled to undergo a total intravenous anesthesia technique
• The history of an allergy to local anesthesia is presented before.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangungkusoma Central Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (3)

• Sato T, Nishiwaki K. Accuracy of landmark scalp blocks performed during asleep-awake-asleep awake craniotomy: a retrospective study. JA Clin Rep. 2021 Jan 9;7(1):8. doi: 10.1186/s40981-021-00412-4. No abstract available.

  PMID: 33420848 BACKGROUND

• Girard F, Quentin C, Charbonneau S, Ayoub C, Boudreault D, Chouinard P, Ruel M, Moumdjian R. Superficial cervical plexus block for transitional analgesia in infratentorial and occipital craniotomy: a randomized trial. Can J Anaesth. 2010 Dec;57(12):1065-70. doi: 10.1007/s12630-010-9392-3. Epub 2010 Sep 28.

  PMID: 20878375 BACKGROUND

• 1. Department of Neurology, Faculty of Medicine, Universitas Indonesia/Rumah Sakit Cipto Mangunkusumo, Jakarta, Indonesia, Aninditha T. Adults brain tumor in Cipto Mangunkusumo General Hospital: A descriptive epidemiology. Ro J Neurol. 31 Desember 2021;20(4):480-4.

  BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Principal Investigator

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 19, 2025
• Study Start: February 18, 2025
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)