At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 70 enrolled
Drug / intervention
Pregabalin +1 moredrug
Likely dose
Pregabalin 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Perioperative Administration of Pregabalin for Pain After Mastectomy
In Brief
A Phase 4 clinical trial evaluating Pregabalin and Vitamin Complex (placebo) for Pain, Postoperative. Completed, enrolled 70 participants across 1 site.
Detailed 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 pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1 week and 1 month after operation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJul 2009
Primary CompletionDec 2009
Study CompletionJan 2010
TodayJul 2026
First PostedJul 14, 2009
Enrollment StartJun 1, 2009
Primary CompletionDec 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.0 years ago
Interventions
Pregabalindrug
Pregabalin 75 mg orally
Vitamin Complex (placebo)drug
Vitamin Complex orally