Effectiveness of peri-operative pregabalin as co-adjuvant analgesic for cosmetic liposuction
| ISRCTN | ISRCTN89891413 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89891413 |
| Protocol serial number | N/A |
| Sponsor | IPS University (IPS Universitaria) (Colombia) - Surgical Ambulatory Unit |
| Funder | IPS University (IPS Universitaria) (Colombia)- Surgical Ambulatory Unit, Department of Anaesthesia |
- 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
Scientific
76 Stuart Street
Kingston General Hospital
Department of Anesthesia
Kingston
K7L2V7
Canada
| Phone | +1 613 985 0424 |
|---|---|
| luisdr74@yahoo.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomised placebo-controlled double-blind parallel multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Pregabalin as co-adjuvant analgesic for pain management after cosmetic liposuction: a randomised, double-blind and placebo-controlled clinical trial of effectiveness |
| Study objectives | 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(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) studied | 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 / device / biological / vaccine name(s) | Pregabalin |
| Primary outcome measure(s) |
Numerical Rating Scale of Pain Intensity at rest and movement-induced at days 1, 2 3 and 4 after surgery |
| Key secondary outcome measure(s) |
1. Post-operative (days 1, 2 3 and 4) morphine-equivalent request |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 110 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Canada
- Colombia
Study participating centre
76 Stuart Street
Kingston
K7L2V7
Canada
K7L2V7
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
