Anesthesia , AnalgesiaPhase 3ULTRASCALPNCT07149077
Echo-guided Scalp Blocks and Incidence of Postoperative Pain in Scheduled Supratentorial Intracranial Surgery.
A Phase 3 study testing Echo-guided scalp blocks and Classic anesthetic strategy in people with Anesthesia , Analgesia, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Up to 30% of patients undergoing intracranial surgery present moderate to severe pain. In this type of surgery, the restriction of the pharmacopoeia, which goes against the concept of multimodal analgesia, results in the important use of opioids not without consequences in terms of complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia , Analgesia
- What is being tested?
- Echo-guided scalp blocks and Classic anesthetic strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient managed in the neurosurgical unit for supratentorial intracranial surgery.
- Person affiliated or beneficiary of a social security plan.
- Free, informed, and written consent signed by the participant and the investigating physician (at the latest on the day of inclusion and before any examination required by the research).
Who cannot join
- Surgical procedure under awake surgery (systematic realization of scalp blocks necessary)
- Aphasia of comprehension preoperatively or expected postoperatively or any other neurological impairment making self-evaluation of pain impossible.
- Contraindication to the use of local anesthetics: allergy or history of intoxication to local anesthetics
- Contraindication to adrenaline infiltration: severe ventricular rhythm disorders, severe obstructive cardiomyopathy, unstable coronary insufficiency, hypersensitivity to adrenaline.
- Chronic pain patient or patient with daily preoperative consumption of morphine
- Pregnant or breast-feeding woman
- Patient under legal protection (persons deprived of liberty or under guardianship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Bordeaux university hospital
Bordeaux
Grégoire CHADEFAUX, MD, +33 5 57 87 02 02, gregoire.chadefaux@chu-bordeaux.fr
Grégoire CANE, MD, +33 5 57 87 02 01, gregoire.cane@chu-bordeaux.fr
About this study
Up to 30% of patients undergoing intracranial surgery present moderate to severe pain. In this type of surgery, the restriction of the pharmacopoeia, which goes against the concept of multimodal analgesia, results in the important use of opioids not without consequences in terms of complications. Numerous studies have highlighted the benefits of scalp blocks in postoperative pain. The originality of this study lies firstly in the fact that the scalp blocks will be guided by ultrasound and secondly, the incidence of severe pain after scalp blocks will be evaluated
Read the detailed description
In neurosurgery, up to 30% of patients experience severe pain (Numeric Pain Rating Scale > 5) after craniotomy. In order to ensure optimal patient comfort during the perioperative period, multimodal analgesia is the rule. However, the use of certain analgesics in this type of surgery is discussed.
The two analgesics most used in this type of surgery are paracetamol and opioids. The latter, used in large quantities, can lead to an increase in drowsiness, disrupt the postoperative neurological clinical examination (Glasgow score, etc.), cause nausea/vomiting or respiratory depression which will increase complications and the length of stay of patients. Despite the use of morphine and its adverse effects, some study highlighted the high incidence of pain, particularly severe pain in post-craniotomy surgery.
Whether it is to improve postoperative pain or to decrease the intraoperative hemodynamic response, many studies have underlined the interest of scalp block in the postoperative analgesia of craniotomies. Even if large randomized clinical trials are necessary, scalp blocks have been evaluated in subdural hematoma evacuation surgeries, in awake neurosurgeries or in Arnold neuralgia. Intraoperative arterial hypertension induces a risk of increased bleeding and an increase in intracranial pressure with the consequent consequences on cerebral perfusion pressure. These hemodynamic variations, whether intra or post operative, are a source of adverse events.
However, the results of the different studies appear to be discordant and are more interested in the comparison of pain scores and not in the incidence of severe pain. Scalp blocks are mostly performed from anatomical landmarks. In addition, the scalp, which is richly vascularized, is a source of intravascular passage of local anesthetics. Ultrasound-guided scalp blocks are part of this morphine-sparing and multimodal analgesia approach and would allow the realization of a locoregional anesthesia by decreasing, through the use of ultrasound, the risks of intravascular injection and the quantity of local anesthetic.
This study is one of the first to evaluate the impact of an ultrasound-guided scalp block on the incidence of severe postoperative pain (Numeric Pain Rating Scale > 4) in supratentorial intracranial surgery.
- Conditions
- Anesthesia , Analgesia
- Being tested
- Echo-guided scalp blocks, Classic anesthetic strategy
- Keywords
- scalp block, neurosurgery, supratentorial surgery, craniotomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echo-guided scalp blocksDrug
Classic anesthetic strategy in association with echo-guided scalp blocks
Classic anesthetic strategyDrug
classic anesthetic strategy with postoperative analgesia associating Paracetamol and Morphine with standardized dose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patient managed in the neurosurgical unit for supratentorial intracranial surgery randomized in the experimental group Receives: Drug: Classic anesthetic strategy |
| Control group | Active comparator | Patient managed in the neurosurgical unit for supratentorial intracranial surgery randomized in the control group Receives: Drug: Echo-guided scalp blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intense post-operative pain
The primary outcome measure will be a composite outcome including:
- Either the need to administer morphine titration at a dose greater than 0.05 mg/kg in the immediate postoperative period (i.e., up to 6 hours after extubation).
- Either the presence of severe pain defined by an episode of visual analog scale > 4 in the immediate postoperative period (i.e., up to 6 hours after extubation).
Measured: up to 6 hours after extubation (day 0)
Secondary outcomes (5)
Absolute pain
Pain will be assessed using a visual analog scale (from 0: no pain to 10: maximum pain).
Measured: at Day 0, hourly until 6 hours after extubation and 24 hours after intervention
Morphine consumption.
Recording the amount of morphine consumed
Measured: at Day 0, hourly until 6 hours after extubation and 24 hours after intervention
Incidence of Postoperative nausea and vomiting
The occurrence of postoperative nausea and vomiting will be recorded and defined by at least one of the following:
- the presence of nausea,
- the need to initiate rescue antiemetic treatment,
- at least one episode of vomiting.
Measured: at day 0 : 6 hours and 24 hours after intervention
Chronic post-operative pain
Presence of persistent headache or neuropathic pain at the scar site using a visual analog scale
Measured: 3 months after Day 0
Infection
The occurrence of an infection at the surgical site will also be recorded.
Measured: 3 months after Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia , AnalgesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparative, superiority, single-center, randomized clinical trial with two parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire CANE, MD, Study director, University Hospital, BordeauxGrégoire CHADEFAUX, MD, Principal investigator, University Hospital, BordeauxAntoine BENARD, MD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149077
- Sponsor's protocol ID
- CHUBX 2023/42
- Acronym
- ULTRASCALP
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echo-guided Scalp Blocks and Incidence of Postoperative Pain in Scheduled Supratentorial Intracranial Surgery.
- ClinicalTrials.gov ID
- NCT07149077
- Acronym / sponsor ID
- ULTRASCALP / CHUBX 2023/42
- Conditions
- Anesthesia , Analgesia
- Keywords
- scalp block, neurosurgery, supratentorial surgery, craniotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 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.
Up to 30% of patients undergoing intracranial surgery present moderate to severe pain. In this type of surgery, the restriction of the pharmacopoeia, which goes against the concept of multimodal analgesia, results in the important use of opioids not without consequences in terms of complications. Numerous studies have highlighted the benefits of scalp blocks in postoperative pain. The originality of this study lies firstly in the fact that the scalp blocks will be guided by ultrasound and secondly, the incidence of severe pain after scalp blocks will be evaluated
Detailed description
In neurosurgery, up to 30% of patients experience severe pain (Numeric Pain Rating Scale > 5) after craniotomy. In order to ensure optimal patient comfort during the perioperative period, multimodal analgesia is the rule. However, the use of certain analgesics in this type of surgery is discussed.
The two analgesics most used in this type of surgery are paracetamol and opioids. The latter, used in large quantities, can lead to an increase in drowsiness, disrupt the postoperative neurological clinical examination (Glasgow score, etc.), cause nausea/vomiting or respiratory depression which will increase complications and the length of stay of patients. Despite the use of morphine and its adverse effects, some study highlighted the high incidence of pain, particularly severe pain in post-craniotomy surgery.
Whether it is to improve postoperative pain or to decrease the intraoperative hemodynamic response, many studies have underlined the interest of scalp block in the postoperative analgesia of craniotomies. Even if large randomized clinical trials are necessary, scalp blocks have been evaluated in subdural hematoma evacuation surgeries, in awake neurosurgeries or in Arnold neuralgia. Intraoperative arterial hypertension induces a risk of increased bleeding and an increase in intracranial pressure with the consequent consequences on cerebral perfusion pressure. These hemodynamic variations, whether intra or post operative, are a source of adverse events.
However, the results of the different studies appear to be discordant and are more interested in the comparison of pain scores and not in the incidence of severe pain. Scalp blocks are mostly performed from anatomical landmarks. In addition, the scalp, which is richly vascularized, is a source of intravascular passage of local anesthetics. Ultrasound-guided scalp blocks are part of this morphine-sparing and multimodal analgesia approach and would allow the realization of a locoregional anesthesia by decreasing, through the use of ultrasound, the risks of intravascular injection and the quantity of local anesthetic.
This study is one of the first to evaluate the impact of an ultrasound-guided scalp block on the incidence of severe postoperative pain (Numeric Pain Rating Scale > 4) in supratentorial intracranial surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- comparative, superiority, single-center, randomized clinical trial with two parallel groups
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Classic anesthetic strategyPatient managed in the neurosurgical unit for supratentorial intracranial surgery randomized in the experimental group |
| Control group | Active comparator | Drug: Echo-guided scalp blocksPatient managed in the neurosurgical unit for supratentorial intracranial surgery randomized in the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient managed in the neurosurgical unit for supratentorial intracranial surgery.
- Person affiliated or beneficiary of a social security plan.
- Free, informed, and written consent signed by the participant and the investigating physician (at the latest on the day of inclusion and before any examination required by the research).
Key exclusion criteria (7 listed)
- Surgical procedure under awake surgery (systematic realization of scalp blocks necessary)
- Aphasia of comprehension preoperatively or expected postoperatively or any other neurological impairment making self-evaluation of pain impossible.
- Contraindication to the use of local anesthetics: allergy or history of intoxication to local anesthetics
- Contraindication to adrenaline infiltration: severe ventricular rhythm disorders, severe obstructive cardiomyopathy, unstable coronary insufficiency, hypersensitivity to adrenaline.
- Chronic pain patient or patient with daily preoperative consumption of morphine
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 |
|---|---|---|
| Echo-guided scalp blocksClassic anesthetic strategy in association with echo-guided scalp blocks | Drug | Control group |
| Classic anesthetic strategyclassic anesthetic strategy with postoperative analgesia associating Paracetamol and Morphine with standardized dose. | Drug | Experimental group |
Primary outcome
Intense post-operative pain
Time frame: up to 6 hours after extubation (day 0)
The primary outcome measure will be a composite outcome including: * Either the need to administer morphine titration at a dose greater than 0.05 mg/kg in the immediate postoperative period (i.e., up to 6 hours after extubation). * Either the presence of severe pain defined by an episode of visual analog scale > 4 in the immediate postoperative period (i.e., up to 6 hours after extubation).
5 secondary outcomes
Absolute pain
Time frame: at Day 0, hourly until 6 hours after extubation and 24 hours after intervention
Morphine consumption.
Time frame: at Day 0, hourly until 6 hours after extubation and 24 hours after intervention
Incidence of Postoperative nausea and vomiting
Time frame: at day 0 : 6 hours and 24 hours after intervention
Chronic post-operative pain
Time frame: 3 months after Day 0
Infection
Time frame: 3 months after Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- 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.
Grégoire CANE, MD study director
University Hospital, Bordeaux
Grégoire CHADEFAUX, MD principal investigator
University Hospital, Bordeaux
Antoine BENARD, MD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Echo-guided scalp blocks and Classic anesthetic strategy in people with Anesthesia , Analgesia, run by University Hospital, Bordeaux at 1 site in France.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 7 Aug 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grégoire Chadefaux, MD (+33 05 57 87 02 02, gregoire.chadefaux@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intense post-operative pain (time frame: up to 6 hours after extubation (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.