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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Echo-guided scalp blocks

    Drug

    Classic anesthetic strategy in association with echo-guided scalp blocks

  • Classic anesthetic strategy

    Drug

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

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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).

Time frame
up to 6 hours after extubation (day 0)

Secondary outcomes

1

Absolute pain

Pain will be assessed using a visual analog scale (from 0: no pain to 10: maximum pain).

Time frame
at Day 0, hourly until 6 hours after extubation and 24 hours after intervention
2

Morphine consumption.

Recording the amount of morphine consumed

Time frame
at Day 0, hourly until 6 hours after extubation and 24 hours after intervention
3

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.

Time frame
at day 0 : 6 hours and 24 hours after intervention
4

Chronic post-operative pain

Presence of persistent headache or neuropathic pain at the scar site using a visual analog scale

Time frame
3 months after Day 0

Other outcomes

Sponsors and contacts

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