Condition category
Surgery
Date applied
07/02/2011
Date assigned
10/03/2011
Last edited
10/03/2011
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 Luis Enrique Chaparro

ORCID ID

Contact details

76 Stuart Street
Kingston General Hospital
Department of Anesthesia
Kingston
K7L2V7
Canada
+1 613 985 0424
luisdr74@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pregabalin as co-adjuvant analgesic for pain management after cosmetic liposuction: a randomised, double-blind and placebo-controlled clinical trial of effectiveness

Acronym

Study hypothesis

Null hypothesis:
Adding pregabalin to a conventional analgesic scheme does not decrease the pain intensity with movement, analgesic request, opioid-related side effects (nausea, vomiting, somnolence) or time elapsed for returning to regular activities in patients undergoing cosmetic liposuction.

Alternate hypothesis:
Adding pregabalin to a conventional analgesic scheme decreases the pain intensity with movement, analgesic request, opioid-related side effects (nausea, vomiting, somnolence), or time elapsed for returning to regular activities in patients undergoing cosmetic liposuction.

Ethics approval

Bioethics Committee of the IPS Universitaria (Universidad de Antioquia) (Comité de Bioética de la IPS Universitaria) (Universidad de Antioquia) approved on the 6th March 2006

Study design

Interventional randomised placebo-controlled double-blind parallel multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Post-operative pain

Intervention

Interventional arm:
Blinded capsules of pregabalin 75 mg. The patients started to take the medication the night before the surgery and continued the prescription twice daily (BID) up to the fourth day after surgery. They also had access to a prescription by the surgeon that included a weak opioid + acetaminophen and ibuprofen 200 mg as the circumstances arises (prn)

Control arm:
Blinded capsules of placebo (physically identical to pregabalin capsules). The patients started to take the placebos the night before the surgery and continued the prescription BID up to the fourth day after surgery. They also had access to a prescription by the surgeon that included a weak opioid + acetaminophen and ibuprofen 200 mg prn.

Intervention type

Drug

Phase

Phase IV

Drug names

Pregabalin

Primary outcome measures

Numerical Rating Scale of Pain Intensity at rest and movement-induced at days 1, 2 3 and 4 after surgery

Secondary outcome measures

1. Post-operative (days 1, 2 3 and 4) morphine-equivalent request
2. Incidence of nausea, vomiting and sedation at the same time-points

Overall trial start date

01/06/2006

Overall trial end date

01/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 18 - 70 years
2. American Society of Anesthesiologists physical status score I - II
3. Scheduled for ambulatory cosmetic liposuction alone, liposuction and augmentation mammaplasty or liposuction and abdominoplasty under general anaesthesia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

110

Participant exclusion criteria

1. Known allergy to any of the medications to be used (pregabalin, ibuprofen, tramadol or codeine)
2. Psychiatric illness
3. Chronic use (greater than 3 months) of steroids
4. Hypertension
5. Diabetes
6. Potential participants who were non-spanish speakers

Recruitment start date

01/06/2006

Recruitment end date

01/09/2007

Locations

Countries of recruitment

Colombia

Trial participating centre

76 Stuart Street
Kingston
K7L2V7
Canada

Sponsor information

Organisation

IPS University (IPS Universitaria) (Colombia) - Surgical Ambulatory Unit

Sponsor details

Carrera 51A #62-42
Medellin
-
Colombia
+57(0) 4263 0171
ipsuniversitaria@ips.udea.edu.co

Sponsor type

University/education

Website

http://ips.udea.edu.co/

Funders

Funder type

University/education

Funder name

IPS University (IPS Universitaria) (Colombia)- Surgical Ambulatory Unit, Department of Anaesthesia

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