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NCT Number: NCT07131046

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangungkusoma Central Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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).

Primary outcomes

  1. Remifentanil consumption for each step of surgery

    Time frame: intraoperative

    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.

  2. The total amount of Remifentanil administered during the operation

    Time frame: Intraoperative

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

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

    Time frame: Intraoperative

    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.

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

    Time frame: Intraoperative

    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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

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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