Pain, PostoperativeNCT06127628
Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy
A study testing Ultrasound-guided scalp block with ropivacaine 0.375% in people with Pain, Postoperative and Anesthesia, run by University Malaysia Sarawak at 1 site in Malaysia.
Trial summary
Pain management in patients undergoing neurosurgery is a very important issue. The effectiveness of USG-guided scalp blocks for pain management in craniotomy surgery is currently not known. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Anesthesia
- What is being tested?
- Ultrasound-guided scalp block with ropivacaine 0.375%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 Apr 2024to 19 Apr 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All American Society of Anesthesia class I to III patients undergoing elective supratentorial craniotomies under general anaesthesia.
Who cannot join
- Refusal to participate in the study
- Contraindications to the performance of scalp block, such as local infections
- Allergy to ropivacaine hydrochloride
- Age < 18 years old
- Undergoing emergency craniotomies, posterior fossa surgery, or burr holes surgery
- Pre-existing chronic pain (defined as persistent or recurrent pain lasting > 3 months)
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- History of drug addiction (illicit substances and opioids use) or chronic alcohol abuse
- Presence of uncontrolled systemic arterial hypertension, severe cardiovascular disease, severe kidney or severe liver diseases
- Predicted to require postoperative ventilation in the intensive care unit
- Psychiatric disorders, serious neurological diseases, or reduced consciousness GCS < 14
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy: a Randomised Controlled Trial
Pain management in patients undergoing neurosurgery is a very important issue. The effectiveness of USG-guided scalp blocks for pain management in craniotomy surgery is currently not known. The purpose of this clinical trial is to evaluate the effectiveness of ultrasound-guided scalp block when performed in patients who undergo supratentorial craniotomies.
Read the detailed description
The main research questions this trial will answer are:
- In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative pain compared to standard treatment?
- In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative opioid consumption compared to standard treatment?
- In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect intraoperative haemodynamic parameters (blood pressure and heart rate) compared to standard treatment?
This clinical trial compares ultrasound-guided scalp block with ropivacaine 0.375% versus standard treatment.
The findings of this clinical trial may potentially revolutionise the practice of regional anaesthesia and analgesia in intracranial surgeries. This will lead to better patient outcomes by improving the perioperative care of patients undergoing craniotomy surgery.
- Conditions
- Pain, Postoperative, Anesthesia
- Being tested
- Ultrasound-guided scalp block with ropivacaine 0.375%
- Keywords
- Scalp block, Pain, Supratentorial craniotomy, Ultrasound
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided scalp block with ropivacaine 0.375%Procedure or surgery
Scalp block will be performed under USG guidance, using the technique described by Tsan et al. The block needle used will be an echogenic block needle, with a length of 50 mm, and a diameter of 22 G. Trained personnel comprising of the investigators in this study will perform the scalp block. Using ultrasound to identify landmarks, ropivacaine 0.375% will be administered in volumes of 1.5 ml to 3 ml. The nerves targeted will be the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater auricular, lesser occipital, greater occipital and third occipital nerves.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided scalp with ropivacaine 0.375% | Experimental | Ultrasound-guided scalp block performed for supraorbital nerve, supratrochlear nerve, zygomaticotemporal nerve, auriculotemporal nerve, superficial cervical plexus, greater occipital nerve and third occipital nerve. The local anaesthetic used will be ropivacaine 0.375%. Receives: Procedure: Ultrasound-guided scalp block with ropivacaine 0.375% |
| Standard treatment | No intervention | Standard perioperative anaesthetic and surgical treatment will be performed, with the omission of ultrasound-guided scalp block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain as measured by the visual analogue scale, with no pain being 0 and the maximal pain possible being 10.
Measured: Pain scores will be measured at 1, 6, 24, and 48 hours after surgery.
Secondary outcomes (3)
Opioid consumption postoperatively
Overall postoperative morphine-equivalent consumption
Measured: Measured at 24 and 48 hours after surgery
Intraoperative blood pressure stability during stimulating points of surgery
Mean arterial pressures in mmHg at skull-pinning, skin incision and craniotomy.
Measured: Measurements will be made at time 0 (before stimulation), time-1 (1 minute after stimulation), time-3 (3 minutes after stimulation) and time-5 (5 minutes after stimulation).
Intraoperative heart rate stability during stimulating points of surgery
Heart rates in beats per minute at skull-pinning, skin incision and craniotomy.
Measured: Measurements will be made at time 0 (before stimulation), time-1 (1 minute after stimulation), time-3 (3 minutes after stimulation) and time-5 (5 minutes after stimulation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start3 Apr 2024
- Primary completion19 Apr 2026
- Study completion19 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Model description
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Malaysia Sarawak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Ern Hung Tsan, University Malaysia Sarawak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127628
- Sponsor's protocol ID
- NMRR ID-23-03179-N5K
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsan SEH, Goh CH, Tan PCS. Ultrasound-Guided Scalp Blocks for an Awake Craniotomy: A Case Report. A A Pract. 2022 Sep 20;16(9):e01618. doi: 10.1213/XAA.0000000000001618. eCollection 2022 Sep 1.
PubMed 36136961
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound-guided Scalp Block for Supratentorial Craniotomy: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06127628
- Acronym / sponsor ID
- NMRR ID-23-03179-N5K
- Conditions
- Pain, Postoperative, Anesthesia
- Keywords
- Scalp block, Pain, Supratentorial craniotomy, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Malaysia SarawakUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 19 Apr 2026 (actual)
- First posted
- 13 Nov 2023 (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.
Pain management in patients undergoing neurosurgery is a very important issue. The effectiveness of USG-guided scalp blocks for pain management in craniotomy surgery is currently not known. The purpose of this clinical trial is to evaluate the effectiveness of ultrasound-guided scalp block when performed in patients who undergo supratentorial craniotomies.
Detailed description
The main research questions this trial will answer are:
- In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative pain compared to standard treatment?
- In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect postoperative opioid consumption compared to standard treatment?
- In patients undergoing elective supratentorial craniotomy under general anaesthesia, does USG-guided scalp block affect intraoperative haemodynamic parameters (blood pressure and heart rate) compared to standard treatment?
This clinical trial compares ultrasound-guided scalp block with ropivacaine 0.375% versus standard treatment.
The findings of this clinical trial may potentially revolutionise the practice of regional anaesthesia and analgesia in intracranial surgeries. This will lead to better patient outcomes by improving the perioperative care of patients undergoing craniotomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel groups
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided scalp with ropivacaine 0.375% | Experimental | Procedure: Ultrasound-guided scalp block with ropivacaine 0.375%Ultrasound-guided scalp block performed for supraorbital nerve, supratrochlear nerve, zygomaticotemporal nerve, auriculotemporal nerve, superficial cervical plexus, greater occipital nerve and third occipital nerve. The local anaesthetic used will be ropivacaine 0.375%. |
| Standard treatment | No intervention | –Standard perioperative anaesthetic and surgical treatment will be performed, with the omission of ultrasound-guided scalp block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All American Society of Anesthesia class I to III patients undergoing elective supratentorial craniotomies under general anaesthesia.
Key exclusion criteria (10 listed)
- Refusal to participate in the study
- Contraindications to the performance of scalp block, such as local infections
- Allergy to ropivacaine hydrochloride
- Age < 18 years old
- Undergoing emergency craniotomies, posterior fossa surgery, or burr holes surgery
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 |
|---|---|---|
| Ultrasound-guided scalp block with ropivacaine 0.375%Scalp block will be performed under USG guidance, using the technique described by Tsan et al. The block needle used will be an echogenic block needle, with a length of 50 mm, and a diameter of 22 G. Trained personnel comprising of the investigators in this study will perform the scalp block. Using ultrasound to identify landmarks, ropivacaine 0.375% will be administered in volumes of 1.5 ml to 3 ml. The nerves targeted will be the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater auricular, lesser occipital, greater occipital and third occipital nerves. | Procedure or surgery | Ultrasound-guided scalp with ropivacaine 0.375% |
Primary outcome
Postoperative pain
Time frame: Pain scores will be measured at 1, 6, 24, and 48 hours after surgery.
Postoperative pain as measured by the visual analogue scale, with no pain being 0 and the maximal pain possible being 10.
3 secondary outcomes
Opioid consumption postoperatively
Time frame: Measured at 24 and 48 hours after surgery
Intraoperative blood pressure stability during stimulating points of surgery
Time frame: Measurements will be made at time 0 (before stimulation), time-1 (1 minute after stimulation), time-3 (3 minutes after stimulation) and time-5 (5 minutes after stimulation).
Intraoperative heart rate stability during stimulating points of surgery
Time frame: Measurements will be made at time 0 (before stimulation), time-1 (1 minute after stimulation), time-3 (3 minutes after stimulation) and time-5 (5 minutes after stimulation).
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 21 Oct 2026.
- Background: PubMed 36136961Tsan SEH, Goh CH, Tan PCS. Ultrasound-Guided Scalp Blocks for an Awake Craniotomy: A Case Report. A A Pract. 2022 Sep 20;16(9):e01618. doi: 10.1213/XAA.0000000000001618. eCollection 2022 Sep 1.
- 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 Ultrasound-guided scalp block with ropivacaine 0.375% in people with Pain, Postoperative and Anesthesia, run by University Malaysia Sarawak at 1 site in Malaysia.
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 1 inclusion and 10 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 21 Oct 2026. 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 Malaysia. 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. 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?
Postoperative pain (time frame: Pain scores will be measured at 1, 6, 24, and 48 hours after surgery.). 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 NCT06127628, which also lists 1 linked publication.
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 21 Oct 2026.