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

IWK Health Centre

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain; Opioid Use

Treatments: Drug: Placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT00781131

IWK-4101-2007

Details and patient eligibility

About

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?

Enrollment: 101 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)))]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

101 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Experimental group

Description:

Pregabalin 75 mg

Treatment:

Drug: Pregabalin

3

Experimental group

Description:

Pregabalin 150 mg

Treatment:

Drug: Pregabalin