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

NCT ID: NCT07131046

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-18
• Study Completion Date: 2025-05-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Combination of superficial cervical plexus block and supraorbital block

Group Type: EXPERIMENTAL

Combination of superficial cervical plexus block and supraorbital block

Intervention Type: 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

Group Type: SHAM_COMPARATOR

Scalp block with bupivacaine alone

Intervention Type: 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).

Interventions

Combination of superficial cervical plexus block and supraorbital block

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.

Intervention Type: PROCEDURE

Scalp block with bupivacaine alone

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Adult patients who have reached an age of 18 years and have not yet reached 65 years of age are included in this study.

3. Patients with ASA classification 1 - 3

4. The patient has expressed their willingness to participate in a research study and has provided their signature on an informed consent form.

Exclusion Criteria

1. The patient has been diagnosed with an infection in the area where the block needle insertion is to be performed.

2. 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.

3. The patient is currently undergoing treatment with a beta-blocker.

4. Patients in whom intraoperative evoked potential monitoring is scheduled.

5. The patient is scheduled to undergo a total intravenous anesthesia technique

6. The history of an allergy to local anesthesia is presented before.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Pryambodho Pryambodho

Anesthesiologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cipto Mangungkusoma Central Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Countries

Indonesia

References

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.

Reference Type: BACKGROUND

PMID: 33420848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20878375 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

IndonesiaUAnes1002

Identifier Type: -

Identifier Source: org_study_id