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

NCT00781131 | Completed Phase 4 DMC

• 1 other identifier: IWK-4101-2007
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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?

Conditions

Postoperative Pain; Opioid Use

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Pregabalin 75 mg

Drug: Pregabalin

3

EXPERIMENTAL

Pregabalin 150 mg

Drug: Pregabalin

Interventions

Pregabalin DRUG

pregabalin 75 or 150 mg

2; 3

Placebo DRUG

lactulose placebo

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

• George RB, McKeen DM, Andreou P, Habib AS. A randomized placebo-controlled trial of two doses of pregabalin for postoperative analgesia in patients undergoing abdominal hysterectomy. Can J Anaesth. 2014 Jun;61(6):551-7. doi: 10.1007/s12630-014-0147-4. Epub 2014 Mar 26.

  PMID: 24668315 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ronald B George, MD FRCPC

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator, MD, FRCPC, Assistant Professor

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 28, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2011
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

CA (1)