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Effect of preoperative oral pregabalin for acute postoperative pain in patients undergoing temporal craniotomy

Effect of preoperative oral pregabalin for acute postoperative pain in patients undergoing temporal craniotomy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027120
Enrollment
Unknown
Registered
2019-11-01
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative pain

Interventions

placebo group:preoperative oral placebo
pregabalin group:preoperative oral placebo 150mg

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing craniotomy via temporal approach; 2. Intracranial space occupying lesions (diameter less than 5cm); 3. Aged 18-65 years; 4. ASA I or II; 5. The operation time was about 5 ± 1 h.

Exclusion criteria

Exclusion criteria: 1. Preoperative VAS score was greater than 0. 2. Preoperative nausea and vomiting; 3. Allergic to pregabalin; 4. Those who are currently taking drugs that may interact with the research drugs; 5. Patients who participated in other clinical studies in the past 30 days; 6. BMI>30; 7. Pregnant or lactating patients; 8. Patients with renal insufficiency (creatinine clearance rate less than 60ml / min); 9. Previous history of heart disease and arrhythmia; 10. Patients with a history of alcohol or drug abuse; 11. Patients with mental or consciousness disorders; 12. Patients with consciousness or mental disorder, aphasia and hearing impairment after operation; 13. It is necessary to operate again due to intracranial hemorrhage or serious brain edema; 14. Patients with non central nervous system tumors.

Design outcomes

Primary

MeasureTime frame
the VAS scores on movement (moving head) at 6 hours after surgery;

Secondary

MeasureTime frame
the VAS scores on movement (moving head) at 24 hours after surgery;the VAS scores on movement (moving head) at 48 hours after surgery;headache and VAS score;Ramsay sedation scale/scores (RSS);nausea;Vomiting;the dosage of analgesic;the dosage of rescue antiemetic;

Countries

china

Contacts

Public ContactJiuhong Liu

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

ljhhyz@126.com+86 13986272259

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026