Craniotomy SurgeryNCT07131046
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
A study testing Combination of superficial cervical plexus block and supraorbital block and Scalp block with bupivacaine alone in people with Craniotomy Surgery and Regional Anaesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Craniotomy Surgery, Regional Anaesthesia, Scalp Block
- What is being tested?
- Combination of superficial cervical plexus block and supraorbital block and Scalp block with bupivacaine alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Feb 2025to 9 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangungkusoma Central Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
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
- Being tested
- Combination of superficial cervical plexus block and supraorbital block, Scalp block with bupivacaine alone
- Keywords
- superficial cervical plexus block, supraorbital nerve block, scalp block, craniotomy, remifentanil, regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of superficial cervical plexus block and supraorbital blockProcedure or surgery
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 aloneProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Combination of superficial cervical plexus block and supraorbital block | Experimental | Not described Receives: Procedure: Combination of superficial cervical plexus block and supraorbital block |
| Scalp block | Sham comparator | Not described Receives: Procedure: Scalp block with bupivacaine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
The total amount of Remifentanil administered during the operation
The total amount of remifentanil that the medical team used during the surgery
Measured: 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.
Measured: 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.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start18 Feb 2025
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Craniotomy SurgeryStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pryambodho Pryambodho, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131046
- Sponsor's protocol ID
- IndonesiaUAnes1002
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33420848Girard 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.
PubMed 208783751. 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07131046
- Acronym / sponsor ID
- IndonesiaUAnes1002
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination of superficial cervical plexus block and supraorbital blockThe 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. | Procedure or surgery | Combination of superficial cervical plexus block and supraorbital block |
| Scalp block with bupivacaine aloneA 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). | Procedure or surgery | Scalp block |
Primary outcome
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.
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Results publication: PubMed 33420848Sato 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.
- Results publication: PubMed 20878375Girard 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.
- Results publication1. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of superficial cervical plexus block and supraorbital block and Scalp block with bupivacaine alone in people with Craniotomy Surgery and Regional Anaesthesia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remifentanil consumption for each step of surgery (time frame: intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07131046, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.