Echo-guided scalp blocks and incidence of postoperative pain in scheduled supratentorial intracranial surgery.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Bordeaux

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2025-06-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bordeaux University Hopital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Demonstrate the efficacy of echo-guided scalp blocks in decreasing the incidence of severe pain in the early postoperative period of supratentorial intracranial surgeries.

Secondary objectives 7

1. Compare ANI (Analgesia Nociception Index) between the two groups after induction, at the time of intubation, Mayfield frame placement and at the time of incision.
2. Compare absolute pain between the two groups. This comparison will be made on the hourly numerical scale up to 6 hours after extubation and at 24 hours post-operatively.
3. Compare perioperative morphine consumption between the two groups. The endpoint will be the amount of morphine consumed hourly up to 6 hours after extubation and at 24 hours post-op.
4. Compare the incidence of post-operative nausea and vomiting (PONV), with the presence of nausea, the need for rescue antiemetic treatment or at least one episode of vomiting as endpoints, collected at 6h and 24h post-operatively.
5. To compare the incidence of chronic post-operative pain and its functional impact in the two groups. The endpoint will be the presence of persistent headache at 3 months after surgery not attributable to another cause. Other endpoints will be the maximum numerical scale for this headache, the DN4 score and the need for level 2 or 3 analgesics to treat this pain.
6. Compare the incidence of surgical site infection in the two groups at 3 months post-op.
7. Study the ease of performing ultrasound-guided blocks. The endpoint will be the number of nerves blocked by ultrasound for each patient.

Conditions and MedDRA coding

supratentorial intracranial surgery with flap creation

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Age > 18 years
2. Patient admitted to the neurosurgical unit for intracranial supratentorial surgery with flap performed
3. Person affiliated with or benefiting from a social security scheme
4. Free, informed and written consent signed by the participant and the investigating physician (no later than the day of inclusion and before any examination required by the research).

Exclusion criteria 7

1. Awake surgical procedure (systematic scalp blocks required)
2. Aphasia of comprehension preoperatively or expected postoperatively, or any other neurological impairment making pain self-assessment impossible
3. Contraindication to the use of local anesthetics: allergy or history of intoxication with local anesthetics
4. Patients with chronic pain or daily pre-operative morphine consumption
5. Contraindication to adrenaline infiltration: severe ventricular rhythm disorders, severe obstructive cardiomyopathy, unstable coronary insufficiency, hypersensitivity to adrenaline.
6. Pregnant or breast-feeding women
7. Patients under legal protection (persons deprived of their liberty or under guardianship).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite criterion of occurrence of events involving : - Either the need for morphine titration at a dosage greater than 0.05 mg.kg-1 in the immediate postoperative period (i.e., up to 6 h after extubation). - or the existence of severe pain defined by a numerical scale episode > 4 in the immediate post-operative period (i.e. up to 6 hours after extubation).

Secondary endpoints 7

1. ANI will be collected after induction, at the time of intubation, at the time of placement of the Mayfield frame and at the time of incision. Doses of hypnotic (propofol) and analgesic (remifentanil) will be recorded at these times.
2. The numerical pain assessment scale will also be collected hourly up to 6 hours after extubation and at 24 hours post-operatively by the nurses in the continuous monitoring unit.
3. The amount of morphine consumed on an hourly basis up to 6 hours after extubation and at 24 hours post-operatively will be collected using the computerized chart in the continuous care unit.
4. The occurrence of post-operative nausea and vomiting will also be collected and defined by at least one of the following: the presence of nausea / the need for rescue antiemetic treatment / at least one episode of vomiting. This criterion is collected at 6 and 24 hours post-operatively on the basis of the data on the placard, and assessed by the nurses in the continuous monitoring unit in accordance with departmental practice.
5. The presence of a persistent headache at 3 months post-op, not attributable to another cause, will be collected by telephone interview. The numerical scale of this headache, if any, the DN4 score and the need to take level 2 or 3 analgesics to treat this pain will also be collected in a declarative manner by telephone by an investigator blinded to the treatment group.
6. The occurrence of surgical site infection will be collected at 3 months post-op.
7. The number of nerves that may have been blocked by ultrasound for each patient will be collected at the time the scalp blocks are made by the practitioner performing them. The approach will also be recorded.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Bordeaux

Sponsor organisation

Centre Hospitalier Universitaire De Bordeaux

Address

12 Rue Dubernat

City

Talence

Postcode

33400

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Principal Investigator

Public contact point

Organisation

Centre Hospitalier Universitaire De Bordeaux

Contact name

Principal Investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications