Phase 4
Completed N=70
Perioperative Administration of Pregabalin for Pain After Mastectomy
Pain, Postoperative
Source: ClinicalTrials.gov NCT00938548 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
May 2010
Primary outcomePrimary: Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. — 7; 5; 6; 5 Units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. |
7; 5; 6; 5; 5; 3 | — |
| PRIMARY Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. |
4; 3; 8; 13; 9; 5 | — |
| SECONDARY Pain Scores (VNRS) at 1 Week and 1 Month After Operation |
2.9; 1.4; 1.7; 0.6 | — |
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesia physical status class I & II
- Age > 20 and < 70 years
- Robot- assisted endoscopic thyroidectomy
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00938548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.