Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06406829
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yuming Peng, Dr
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Postoperative Pain, Analgesia, Supratentorial Brain Tumor

Additional Details

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.

Arms & Interventions

Arms

Experimental: Local analgesic techniques + dexmedetomidine group

The patients in this group will be received scalp nerve block before surgery with 0.5% ropivacaine. The patients also will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery.

Experimental: Local analgesic techniques and placebo dexmedetomidine group

The patients in this group will be received scalp nerve block before surgery with 0.5% ropivacaine. For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine during surgery and for 48 hours after surgery.

Experimental: Placebo local analgesic techniques and dexmedetomidine group

The patients in this group will not receive scalp nerve block. The patients will be given dexmedetomidine intravenously at a rate of 0.4 μg/kg/h from skin incision until the beginning of dura mater closure, and will be adjusted to 0.05 μg/kg/h for 48 hours after surgery.

Placebo Comparator: Placebo local analgesic techniques and placebo dexmedetomidine group

The patients in this group will not receive scalp nerve block before surgery . For dexmedetomidine placebo group, normal saline will be infused at the same rate as dexmedetomidine group during surgery and for 48 hours after surgery.

Interventions

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.

Drug: - 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.

Other: - no Local analgesic techniques

No Local analgesic techniques will be given.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Yuming Peng, Dr

[email protected]

8610-59976658

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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