The effect of pregabalin on post-operative pain and recovery after kidney transplantation [Pregabaliinin vaikutus leikkauskipuun ja toipumiseen munuaisensiirtopotilailla]
| ISRCTN | ISRCTN46781597 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46781597 |
| Secondary identifying numbers | KirKipu09-1 |
- Submission date
- 01/10/2010
- Registration date
- 20/10/2010
- Last edited
- 20/10/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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 Vesa Kontinen
Scientific
Scientific
Helsinki University Central Hospital
Unit of Surgery, Section of Anaesthesiology, Pain Relief
P.O.Box 263, FI-00029 HUS
Finland
Helsinki
FI-00029 HUS
Finland
Study information
| Study design | Double blind randomised active-placebo controlled parallel-group phase IV clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of pregabalin on post-operative pain and recovery after kidney transplantation: a double blind, randomised, active-placebo controlled parallel-group clinical trial |
| Study objectives | Premedication with pregabalin will reduce post-operative pain after kidney transplantation. |
| Ethics approval(s) | Helsinki University Central Hospital (Helsingin ja Uudenmaan sairaanhoitopiiri) Ethics Committee approved on the 14th October 2009 |
| Health condition(s) or problem(s) studied | Postoperative pain |
| Intervention | Treatment arm: single dose of pregabalin (150 mg if body weight 40 - 80 kg and 300 mg if body weight 80 - 120 kg) orally as premedication 1 hour before entering operating suite. Control arm: single dose of diazepam (7.5 mg if body weight 40 - 80 kg and 15 mg if body weight 80 - 120 kg) orally as premedication 1 hour before entering operating suite. Follow-up 14 days after the operation in both arms. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Pregabalin |
| Primary outcome measure | PCA opioid (oxycodone) consumption 24 after the operation |
| Secondary outcome measures | 1. Patient-reported pain in rest and movement, type of movement provoking pain, dizziness, tiredness, nausea and vomiting, bladder irritation, bowel movements, self-reported overall ability and mood, measured every 12 hours from the first post-operative day to 14 days after the operation 2. Assessment of sedation and anxitety when entering operating suite (1 hour after drug administration) 3. Assessment of pain, bladder irritation, nausea and vomiting, dizziness and sedation and patient-reported symptoms measured at 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 240 minutes and 6 and 8 hours after the end of the operation 4. Bowel function and kidney function 5. Blood sample for measurement of plasma pregabalin concentration taken at 2, 8, 16 and 24 hours after drug administration |
| Overall study start date | 01/04/2010 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 140 |
| Key inclusion criteria | 1. Patients receiving allogenic kidney transplant from a brain-dead donor volunteering to participate 2. Male and female, over 18 years, no study-related upper age limit (but very old persons are usually not accepted as recipients for a kidney transplant) |
| Key exclusion criteria | 1. Chronic opioid or gabapentinoid treatment 2. Unable to communicate in Finnish or Swedish language 3. Krooninen opioidilääkitys 4. Unable to use PCA 5. Unable to use NRS (numeral rating scale) for pain assessment 6. Allergy to pregabalin, oxycodone, propofol or remifentanil 7. Body weight less than 40 kg or greater than 120 kg |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Finland
Study participating centre
Helsinki University Central Hospital
Helsinki
FI-00029 HUS
Finland
FI-00029 HUS
Finland
Sponsor information
Helsinki University Central Hospital (Finland)
Hospital/treatment centre
Hospital/treatment centre
Pain Research Group
Unit of Surgery, Section of Anaesthesiology
P.O.Box 263
Helsinki
FI-00029 HUS
Finland
"ROR" |
https://ror.org/02e8hzf44 |
|---|
Funders
Funder type
Hospital/treatment centre
Helsinki University Central Hospital (Finland) - research funds
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
