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
Protocol serial number	KirKipu09-1
Sponsor	Helsinki University Central Hospital (Finland)
Funder	Helsinki University Central Hospital (Finland) - research funds

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

Primary study design	Interventional
Study design	Double blind randomised active-placebo controlled parallel-group phase IV clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Pregabalin
Primary outcome measure(s)	PCA opioid (oxycodone) consumption 24 after the operation
Key secondary outcome measure(s)	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
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes