Analgesia, Postoperative Pain, Supratentorial Brain Tumor
Conditions
Keywords
multimodal analgesia, Postoperative acute pain
Brief 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.
Detailed 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.
Interventions
DRUGDexmedetomidine
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.
DRUGNormal saline
In the placebo group, the 0.9% saline is administered with the same volume at the same speed as the dexmedetomidine group
OTHERLocal analgesic techniques
As for scalp nerve block, each nerve will be blocked separately with 1-2 mL of 0.67 % liposomal bupivacaine
OTHERno Local analgesic techniques
No Local analgesic techniques will be given.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively. | 48 hours postoperatively | Cumulative amount of sufentanil used by patient-controlled analgesia (PCIA) in patients within 48 hours postoperatively. |
Contacts
CONTACTYuming Peng, Dr
CONTACTMin Zeng, Dr
PRINCIPAL_INVESTIGATORYuming Peng, Dr
Beijing Tiantan Hospital
Outcome results
None listed