Echo-guided Scalp Blocks and Incidence of Postoperative Pain in Scheduled Supratentorial Intracranial Surgery.

NCT07149077 | Not Yet Recruiting Phase 3

• 1 other identifier: CHUBX 2023/42
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Anesthesia , Analgesia

Keywords

scalp block; neurosurgery; supratentorial surgery; craniotomy

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 6 hours after extubation (day 0)

Secondary Outcomes (5)

• Absolute pain

  at Day 0, hourly until 6 hours after extubation and 24 hours after intervention

• Morphine consumption.

  at Day 0, hourly until 6 hours after extubation and 24 hours after intervention

• Incidence of Postoperative nausea and vomiting

  at day 0 : 6 hours and 24 hours after intervention

• Chronic post-operative pain

  3 months after Day 0

• Infection

  3 months after Day 0

Study Arms (2)

Experimental group

EXPERIMENTAL

Patient managed in the neurosurgical unit for supratentorial intracranial surgery randomized in the experimental group

Drug: Classic anesthetic strategy

Control group

ACTIVE COMPARATOR

Patient managed in the neurosurgical unit for supratentorial intracranial surgery randomized in the control group

Drug: Echo-guided scalp blocks

Interventions

Echo-guided scalp blocks DRUG

Classic anesthetic strategy in association with echo-guided scalp blocks

Control group

Classic anesthetic strategy DRUG

classic anesthetic strategy with postoperative analgesia associating Paracetamol and Morphine with standardized dose.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient managed in the neurosurgical unit for supratentorial intracranial surgery.
• Person affiliated or beneficiary of a social security plan.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux university hospital

Bordeaux, France

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Grégoire CANE, MD

  University Hospital, Bordeaux

  STUDY DIRECTOR

• Grégoire CHADEFAUX, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital, Bordeaux

  STUDY CHAIR

Central Study Contacts

Grégoire Chadefaux, MD

CONTACT

+33 05 57 87 02 02; gregoire.chadefaux@chu-bordeaux.fr

Grégoire CANE, MD

CONTACT

+33 05 57 87 02 01; gregoire.cane@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: comparative, superiority, single-center, randomized clinical trial with two parallel groups

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)