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

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 designDouble blind randomised active-placebo controlled parallel-group phase IV clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effect of pregabalin on post-operative pain and recovery after kidney transplantation: a double blind, randomised, active-placebo controlled parallel-group clinical trial
Study objectivesPremedication 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) studiedPostoperative pain
InterventionTreatment 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Pregabalin
Primary outcome measurePCA opioid (oxycodone) consumption 24 after the operation
Secondary outcome measures1. 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 date01/04/2010
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants140
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2010
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Finland

Study participating centre

Helsinki University Central Hospital
Helsinki
FI-00029 HUS
Finland

Sponsor information

Helsinki University Central Hospital (Finland)
Hospital/treatment centre

Pain Research Group
Unit of Surgery, Section of Anaesthesiology
P.O.Box 263
Helsinki
FI-00029 HUS
Finland

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan