Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00785382

Enrollment

Registered

2008-11-05

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2012-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Pain, Pregabalin, Lyrica, Breast surgery

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?

Interventions

DRUGPlacebo

Lactulose Placebo

DRUGPregabalin 150 mg

150 mg Q12H x 2 doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 65 Years

Healthy volunteers

Yes

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 \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation	48 hours

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026