Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy

A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00781131

Enrollment

101

Registered

2008-10-28

Start date

2008-05-31

Completion date

2011-01-31

Last updated

2013-05-23

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

Conditions

Opioid Use, Postoperative Pain

Brief summary

We hypothesize that pregabalin will decrease post-operative pain scores and opioid use following abdominal hysterectomy compared to placebo. This study has been designed to determine if after an abdominal hysterectomy, the addition of pregabalin to their peri-operative analgesia regimen will demonstrate superior analgesia compared to placebo in terms of lower pain scores and reduced usage of opioids. The primary outcome will be post-operative pain, measured by total opioid consumption. Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?

Interventions

DRUGPregabalin

pregabalin 75 or 150 mg

DRUGPlacebo

lactulose placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. American Society of Anesthesia physical status class I & II 2. Age \> 18 years 3. English-speaking 4. Capability to operate a patient-controlled analgesia (PCA) device

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?	1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026