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| [ Print-friendly version ] |
| Pre-operative DNIC testing to identify patients at risk for postoperative pain after living donor nephrectomy |
| ISRCTN | ISRCTN11426614 |
| DOI | 10.1186/ISRCTN11426614 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Pre-operative DNIC testing to identify patients at risk for postoperative pain after living donor nephrectomy |
| Scientific title | Pre-operative DNIC testing to identify patients at risk for postoperative pain after living donor nephrectomy |
| Acronym | N/A |
| Serial number at source | NL36751.078.11 |
| Study hypothesis |
Can the diffuse noxious inhibitory controls (DNIC) test be used to make a prediction of postoperative pain perception and consumption of analgesics after live donor nephrectomy?
Secondary objectives: Is there a correlation between the quality of life and pain perception and consumption of analgesics? |
| Lay summary |
Background and study aims
Live donor nephrectomy is performed on healthy individuals who do not receive direct therapeutic benefit of the procedure themselves. Due to supreme minimal invasive procedures nowadays, research is not only focussed on the fine-tuning of these techniques, but also on the quality of life and postoperative pain. Despite the uniform approach a large variation is seen in postoperative pain. One of the explanations could be an individual difference in diffuse noxious inhibiting control (DNIC). The functionality of DNIC seems to be a predictor for acute post surgical pain and chronic postsurgical pain. The functionality of this pain-inhibitory system can be easily tested in an experimental setting with quantitative sensory testing techniques. Preoperative pain registration with questionnaires combined with DNIC testing is a potential predictor for postoperative pain perception. In the unique group of healthy living kidney donors it is important to set a high standard of care and try to minimize all ‘sideeffects’ of the operation. If the function of DNIC is disturbed this will presumably lead to more postoperative pain. Insight in the differences in DNIC would give us the opportunity to intervene and develop a ‘tailor-made’ management for each specific patient. Who can participate? Any live kidney donor older than 18 years can participate in this study. What does the study involve? Pre-operatively, included donors undergo the DNIC-test. The device that will be used is the STMISOL-device from BIOPAC Systems Inc. The donor will be asked what his or her dominant arm is, after which the donor lies down and will be connected through several wires from the contra lateral groin to a computer. Through these wires an increasing stimulus is given. The donor is capable of stopping the stimulus at any time. An extra emergency-button is installed. Three thresholds are measured, namely the threshold when the stimulus is first felt, the threshold when the stimulus becomes painful and the threshold when the pain tolerance is reached. These measurements are repeated three times. Afterwards, the donor is asked to put his or her dominant (contra lateral) hand in ice-water (2°C) for as long as possible (maximum 3 minutes). Then the measurements as mentioned above are repeated, again 3 times. The difference between the thresholds is an estimate of the DNIC function. Donor nephrectomy will take place following standardized techniques. Postoperative analgesics will be given per protocol, donors receive a patient-controlled analgesia (PCA)-device and oral analgesics (paracetamol). Donors will be asked to keep track of their pain score and fill out questionnaires. There are no further additional procedures. What are the possible benefits and risks of participating? There are no direct benefits for the donor. The risks of this study are negligible since the DNIC-test has been validated and is already extensively used in other studies investigating pain perception. Where is the study run from? The study only runs in the Erasmus MC, University Medical Center Rotterdam, the Netherlands. When is the study starting and how long is it expected to run for? The study started in October 2011 and was completed in February 2012. Who is funding the study? Erasmus MC, University Medical Center. Who is the main contact? J.A. Lafranca, MD, PhD-candidate j.lafranca@erasmusmc.nl |
| Ethics approval | Medical Ethics Research Committee (METC) of the Erasmus Medical Centre in Rotterdam, The Netherlands, 23 August 2011, Ref.nr.: MEC-2011-212 NL36751.078.11 |
| Study design | Single-center observational prospective cohort study |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Postoperative pain perception after live donor nephrectomy |
| Participants - inclusion criteria |
1. Adult (>18 years) living kidney donors
2. Donors must fully comprehend the Dutch language |
| Participants - exclusion criteria |
1. Donors younger than 18 years
2. Donors who not fully comprehend the Dutch language 3. Mental retardation |
| Anticipated start date | 03/10/2011 |
| Anticipated end date | 06/02/2012 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 20 |
| Interventions |
As standard, the kidney donors will be admitted one day prior to surgery. On this day they will undergo the DNIC-test. The DNIC-test will be performed by only one person, qualified to do this test. The device that will be used is the STMISOL-device from BIOPAC Systems Inc.* This device is one of the most accurate to measure pain perception and pain tolerance. The donor will be asked what his or her dominant arm is, after which the donor lies down and will be connected through several wires from the contralateral groin to a computer. Through these wires an increasing stimulus is given. The donor is capable of stopping the stimulus at any time. An extra emergency-button is installed. Three thresholds are measured, namely the threshold when the stimulus is first felt, the threshold when the stimulus becomes painful and the threshold when the pain tolerance is reached. These measurements are repeated three times. Afterwards, the donor is asked to put his or her dominant (contralateral) hand in ice-water (2°C) for as long as possible (maximum 3 minutes). Then the measurements as mentioned above are repeated, again three times. The difference between the thresholds is an estimate of the DNIC function. Donor nephrectomy will take place following standardized techniques. Postoperative analgesics will be given per protocol, donors receive a patient-controlled analgesia (PCA)-device and oral analgesics (paracetamol). Donors will be asked to keep track of their pain score [Visual Analogue Scale (VAS-score)] fill out a quality of life questionnaire (SF-36) and fill out the EuroQol (EQ-5D) questionnaire at different times. There are no further additional procedures.
*. The quality management system of BIOPAC Systems, Inc. has been assessed by NSFISR and found to be in conformance to the following standard(s): ISO 9001:2008. |
| Primary outcome measure(s) | Can the DNIC test be used to make a prediction of postoperative pain perception and consumption of analgesics after live donor nephrectomy? |
| Secondary outcome measure(s) |
1. Is there a correlation between the quality of life and pain perception and consumption of analgesics?
2. Hospital stay 3. Return to normal daily activities 4. Intra and postoperative complications |
| Sources of funding | Erasmus MC, University Medical Center (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Prof F.J.P.M. Huygen |
| Address |
Department of Anesthesiology
's Gravendijkwal 230 |
| City/town | Rotterdam |
| Zip/Postcode | 3015 CE |
| Country | Netherlands |
| f.huygen@erasmusmc.nl | |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Address |
University Medical Center
's Gravendijkwal 230 |
| City/town | Rotterdam |
| Zip/Postcode | 3015 CE |
| Country | Netherlands |
| j.lafranca@erasmusmc.nl | |
| Sponsor website: | http://www.erasmusmc.nl |
| Date applied | 26/11/2012 |
| Last edited | 25/02/2013 |
| Date ISRCTN assigned | 25/02/2013 |
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