Condition category
Surgery
Date applied
03/01/2007
Date assigned
13/02/2007
Last edited
13/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.pfizer.ca

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes