Status:
COMPLETED
Perioperative Administration of Pregabalin for Pain After Mastectomy
Lead Sponsor:
Severance Hospital
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
21-69 years
Phase:
PHASE4
Brief Summary
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. The primary outcome will be acute postoperative...
Eligibility Criteria
Inclusion
- American Society of Anesthesia physical status class I \& II
- Age \> 20 and \< 70 years
- Robot- assisted endoscopic thyroidectomy
Exclusion
- Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
- Body mass index ≥ 40 kg/m2
- History of seizure disorder
- Current therapy with pregabalin, gabapentin, or any opioid
- Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
- Insulin-dependent diabetes mellitus
- Renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2)
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00938548
Start Date
June 1 2009
End Date
January 1 2010
Last Update
May 25 2010
Active Locations (1)
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1
Department of Anesthesiology and Pain Medicine and Anesthesia
Seoul, South Korea, 120-752