CompletedNot Applicable

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

Indonesia41 participantsStarted 2025-02-18

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Remifentanil consumption for each step of surgery

Timeframe: intraoperative

The total amount of Remifentanil administered during the operation

Timeframe: Intraoperative

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

Timeframe: Intraoperative

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

Timeframe: Intraoperative

Trial details

NCT IDNCT07131046

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-09

View on ClinicalTrials.gov More Craniotomy Surgery trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Remifentanil consumption for each step of surgery

Timeframe: intraoperative

The total amount of Remifentanil administered during the operation

Timeframe: Intraoperative

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

Timeframe: Intraoperative

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

Timeframe: Intraoperative