Perioperative Multimodal Analgesia for Supratentorial Craniotomy

ConditionsPostoperative Pain Analgesia Supratentorial Brain Tumor

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorBeijing Tiantan Hospital

About this trial

This randomized clinical trial aims to evaluate the effectiveness of scalp nerve blocks and dexmedetomidine in reducing opioid use and preventing postoperative delirium in patients undergoing supratentorial brain tumor surgery. A total of 2000 patients will be randomly assigned to one of four groups, receiving either active treatments, placebos, or their combinations. The main outcome measured will be the amount of opioid pain medication needed after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged from 18 to 65 years

American Society of Anesthesiologists physical status I to III

Scheduled to undergo elective supratentorial tumor resection

Disqualifiers

Incision-area skin infection

A history of previous craniotomy

Allergy to study medications

A history of preoperative change in consciousness or cognitive function

Trial design

Design model

Factorial

Treatments tested in this trial

Dexmedetomidine
Drug
The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/h intraoperatively and 0.05 μg/kg/h for 48 hours after surgery.
Scalp-Nerve Block
Procedure/Surgery
The 10ml 1.33% liposomal bupivacaine will be diluted into a 20ml syringe. As for scalp nerve block, each nerve will be blocked separately with 1-2 mL 0.67% liposomal bupivacaine.

Treatment groups

2,000 Participants

are divided into 4 treatment groups

Group A: Scalp nerve blocks plus placebo dexmedetomidine infusionExperimental treatment 1 intervention

Group B: Placebo scalp nerve blocks plus dexmedetomidine infusionExperimental treatment 1 intervention

Group C: Both active treatmentsExperimental treatment 2 interventions

Group D: Double placeboNo intervention 0 interventions

Trial outcomes

Primary outcomes

Cumulative sufentanil consumption delivered by patient-controlled intravenous analgesia during the first 48 h post-operatively

Time frame

48 hours postoperatively

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: