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
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