The effect of pregabalin on post-operative pain and recovery after kidney transplantation [Pregabaliinin vaikutus leikkauskipuun ja toipumiseen munuaisensiirtopotilailla]
- Conditions
- Postoperative painSigns and SymptomsPain
- Registration Number
- ISRCTN46781597
- Lead Sponsor
- Helsinki University Central Hospital (Finland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 140
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PCA opioid (oxycodone) consumption 24 after the operation
- Secondary Outcome Measures
Name Time Method 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<br>2. Assessment of sedation and anxitety when entering operating suite (1 hour after drug administration)<br>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<br>4. Bowel function and kidney function<br>5. Blood sample for measurement of plasma pregabalin concentration taken at 2, 8, 16 and 24 hours after drug administration