postoperative pain after craniotomy
Conditions
Interventions
study group:skin infiltration with 0.5%ropivacaine
Control:Placebo (0.9% NS)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female or male, and any race, Age older than 18 years at the screening visite; 2. Scheduled to undergo craniotomy under general anesthesia; 3. Patients with ASA I and II; 4. Female subjects must have been postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days before study drug administration), effective double-barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy. If of childbearing potential,have a documented negative blood or urine pregnancy test within 24 hours before surgery; 5. To be able to provide informed consent, adhere to the study visite schedule, and complete all study assessments.
Exclusion criteria
Exclusion criteria: 1. Under intravertebral anesthesia and/or epidural analgesia; 2. Under postoperatived patient-controlled epidural analgesia (PCEA) and postoperative intravenous analgesia(PCIA); 3. Inability to understand and use the visual analog scale (VAS); 4. Currently pregnant,nursing,or planning to become pregnant during the study or within one month after study drug administration; 5. Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3months, or non-opioid pain medications more than 5times per week; 6. Proven or suspected allergy to local anesthetics, NSAIDs and opioids; 7. Use of any NSAIDs including selective COX-2inhibitor, opioids or other analgesic agents within 3days of surgery; 8. Glasgow Coma Score less than 15; 9. History of suspected or known addiction to or abuse of drugs or alcohol within the past 2 years; 10. Current acute or chronic medical or major psychiatric disease that, in the opinion of the investigator, would interfere with the evaluation of study drug efficacy or safety; 11. Any other subjects were not suitable to this study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total postoperative consumption, in mg, of Morphine through 24 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS pain scores at postoperative hours 2, 4, 8, 24;Propotion of subjects who were pain free (defined as an VAS of 0 or 1) at 24hours and other time points;Proportion of subjects who received no recue pain medication;Time to first postoperative use of supplementary analgesic medication;Subject's satisfactory of postoperative analgesia at 24h;Length of hospital stay;Length of wound pain by patient self report at Day 90; | — |
Contacts
Public ContactYu Li
West China Hospital, Sichuan University
Outcome results
None listed