Phase 4 N=70 Randomized Triple-blind Treatment

Perioperative Administration of Pregabalin for Pain After Mastectomy

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT00938548 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2010

Primary outcome: Primary: Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. — 7; 5; 6; 5 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Pregabalin (Drug); Vitamin Complex (placebo) (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: Severance Hospital
Primary completion: Dec 2009

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	—

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.

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)

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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.