Condition category
Signs and Symptoms
Date applied
01/10/2010
Date assigned
20/10/2010
Last edited
20/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vesa Kontinen

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

KirKipu09-1

Study information

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

Acronym

Study hypothesis

Premedication with pregabalin will reduce post-operative pain after kidney transplantation.

Ethics approval

Helsinki University Central Hospital (Helsingin ja Uudenmaan sairaanhoitopiiri) Ethics Committee approved on the 14th October 2009

Study design

Double blind randomised active-placebo controlled parallel-group phase IV clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Pregabalin

Primary outcome measures

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 trial start date

01/04/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant 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

Recruitment start date

01/04/2010

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Finland

Trial participating centre

Helsinki University Central Hospital
Helsinki
FI-00029 HUS
Finland

Sponsor information

Organisation

Helsinki University Central Hospital (Finland)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Helsinki University Central Hospital (Finland) - research funds

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes