Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

Postoperative Pain Clinical Trial

Official title:

A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785382
• Other study ID #: IWK-4298-2008
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2008
• Last updated: October 30, 2012
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Placebo
Lactulose Placebo
• Pregabalin 150 mg
150 mg Q12H x 2 doses

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation		48 hours	Yes