Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Placebo; Drug: Pregabalin 150 mg

• Registration Number: NCT00785382
• Lead Sponsor: IWK Health Centre

Brief Summary

We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score in the first 24 hours after their surgery than those women who received placebo?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-30
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

1. American Society of Anesthesia physical status class I & II
2. Age ¬< 65 years
3. English-speaking
4. Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)

Exclusion Criteria

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin
2. Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
3. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
4. History of a seizure disorder
5. Pregnancy
6. Current pre-operative therapy with pregabalin, gabapentin, or any opioid
7. Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection
8. CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	Pregabalin 150 mg	-

Primary Outcome Measures

Name	Time	Method
The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.	24 hours

Secondary Outcome Measures

Name	Time	Method
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation	48 hours

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada