The effect of pregabalin on post-operative pain and recovery after kidney transplantation [Pregabaliinin vaikutus leikkauskipuun ja toipumiseen munuaisensiirtopotilailla]

The effect of pregabalin on post-operative pain and recovery after kidney transplantation: a double blind, randomised, active-placebo controlled parallel-group clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN46781597

Enrollment

140

Registered

2010-10-20

Start date

2010-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain Signs and Symptoms Pain

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
PCA opioid (oxycodone) consumption 24 after the operation	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Finland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026