Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

Postoperative Pain Clinical Trial

Official title:

Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy：a 2× 2 Factorial Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06406829
• Other study ID #: 2024007
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Beijing Tiantan Hospital
• Contact: Yuming Peng, Dr
• Phone: 8610-59976658
• Email: florapym766[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Supratentorial craniotomy is one of the most common neurosurgical procedures, with severe perioperative pain. Inadequate perioperative pain relief has been associated with increased blood pressure and intracranial pressure, favoring bleeding and cerebral cerebral hypoperfusion. The ideal analgesia for neurosurgery requires complete pain relief, eliminates the side effects of opioid drugs and no influence for neurological function. Previous studies have proposed a multimodal analgesic strategy, combining analgesics and local anaesthesia, it is expected to achieve the above benefits.

Description:

The trial has been designed to analyze the efficacy of local analgesic techniques and dexmedetomidine in the treatment of postoperative acute pain in craniotomy. This randomized clinical trial aims to enroll 2000 patients, which will be randomized to one of 4 groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged from 18 to 65 years
• American Society of Anesthesiologists physical status I to III
• Scheduled to undergo elective supratentorial tumor resection

Exclusion Criteria:

• Incision-area skin infection
• A history of previous craniotomy
• Allergy to study medications
• A history of preoperative change in consciousness or cognitive function
• Severe hepatic or renal dysfunction
• Severe bradycardia (heart rate<40 beats/min)
• Sick sinus syndrome or second- to-third degree atrioventricular block

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Postoperative Pain
• Supratentorial Brain Tumor

Intervention

Drug:
• Dexmedetomidine
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.
• Normal saline
In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group

Other:
• Local analgesic techniques
The 10ml 1% ropivacaine will be diluted into a 20ml syringe . As for scalp nerve block, each nerve will be blocked separately with 1-2 mL 0.5% ropivacaine.
• no Local analgesic techniques
No Local analgesic techniques will be given.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.	Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively.	48 hours postoperatively