Effectiveness of peri-operative pregabalin as co-adjuvant analgesic for cosmetic liposuction

ISRCTN ISRCTN89891413
DOI https://doi.org/10.1186/ISRCTN89891413
Secondary identifying numbers N/A
Submission date
07/02/2011
Registration date
10/03/2011
Last edited
10/03/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Luis Enrique Chaparro
Scientific

76 Stuart Street
Kingston General Hospital
Department of Anesthesia
Kingston
K7L2V7
Canada

Phone +1 613 985 0424
Email luisdr74@yahoo.com

Study information

Study designInterventional randomised placebo-controlled double-blind parallel multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titlePregabalin as co-adjuvant analgesic for pain management after cosmetic liposuction: a randomised, double-blind and placebo-controlled clinical trial of effectiveness
Study objectivesNull 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(s)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
Health condition(s) or problem(s) studiedPost-operative pain
InterventionInterventional 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Pregabalin
Primary outcome measureNumerical Rating Scale of Pain Intensity at rest and movement-induced at days 1, 2 3 and 4 after surgery
Secondary outcome measures1. Post-operative (days 1, 2 3 and 4) morphine-equivalent request
2. Incidence of nausea, vomiting and sedation at the same time-points
Overall study start date01/06/2006
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants110
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2006
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • Canada
  • Colombia

Study participating centre

76 Stuart Street
Kingston
K7L2V7
Canada

Sponsor information

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

Carrera 51A #62-42
Medellin
-
Colombia

Phone +57(0) 4263 0171
Email ipsuniversitaria@ips.udea.edu.co
Website http://ips.udea.edu.co/

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan