Contact information
Type
Scientific
Primary contact
Dr Philip Peng
ORCID ID
Contact details
McL 2-405
Toronto Western Hospital
399 Bathurst Street
Toronto
M5T 2S8
Canada
+1 (1)416 603 5118
philip.peng@uhn.on.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Pregabalin provides superior post-operative pain control, lower analgesic consumption and better recovery profile compared with placebo.
Ethics approval
Approval received from the University Health Network Research Ethic Board, Toronto, Ontario, Canada, on the 15th December 2006 (ref: UHN REB 05-0745-B).
Study design
Double blind, randomised, controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Postoperative pain during laparoscopic cholecystectomy
Intervention
During laparoscopic cholecystectomy depending on the randomised three groups patients will receive three doses of pregabalin 50 mg/75 mg, first dose one hour after surgery and then every twelve hours or oral placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
Pregabalin
Primary outcome measure
1. Postoperative pain score (Numerical Rating Score [NRS]) in Post Anaesthesia Care Unit (PACU), one hour, six hours, day one, day two and day seven after surgery at rest and movement
2. Time to first analgesic consumption
3. Discharge time from PACU
4. Consumption of analgesics in the postoperative period up to day seven
Secondary outcome measures
1. General tolerability of the regimens
2. Sleep quality
3. Quality of Recovery 40-item questionnaire (QoR-40)
4. Adverse effects including Opioid-Related Symptom Distress Scale (ORSDS)
5. Patient satisfaction
Overall trial start date
21/01/2007
Overall trial end date
21/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients 18 to 65 years of age undergoing cholecystectomy under general anesthesia
2. Able to tolerate standard medications - 1000 mg of acetaminophen and 500 mg of naproxen
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
135
Participant exclusion criteria
1. Clinically diagnosed acute pancreatitis requiring urgent cholecystectomy
2. Allergy to gabapentin or pregabalin
3. Allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAID) or acetaminophen
4. No analgesic within 24 hours before surgery (other than premedication)
5. Patients with Body Mass Index (BMI) more than 40
6. Serious organ disease
7. Creatinine clearance less than or equal to 60 mL
8. Chronic pain patients requiring more than 30 mg morphine per day or equivalent
9. Severe psychiatric disease
10. Drug addiction
11. Pregnancy
12. Language barrier
Recruitment start date
21/01/2007
Recruitment end date
21/06/2008
Locations
Countries of recruitment
Canada
Trial participating centre
McL 2-405
Toronto
M5T 2S8
Canada
Sponsor information
Organisation
Pfizer (Canada)
Sponsor details
17300 Trans-Canada Highway
Kirkland
Quebec
H9J 2M5
Canada
Sponsor type
Industry
Website
Funders
Funder type
University/education
Funder name
Support from Department of Anesthesiology and Pain Management, University of Toronto (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list