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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN45530042 |
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Date of registration:
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03/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Continuous administration of local anesthetic for pain after amputation above knee
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Scientific title:
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Peripheral local anesthetic infusion for postoperative pain after above knee amputation |
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Date of first enrolment:
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01/09/2014 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN45530042 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled double-blind study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Finland
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Contacts
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Name:
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Vesa
Kontinen |
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Address:
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HUS Jorvin sairaala
00029 HUS
Espoo
Finland |
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Telephone:
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- |
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Email:
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vesa.kontinen@helsinki.fi |
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Affiliation:
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Name:
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Address:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients presenting for above knee amputation for atherosclerosis obliterans willing to participate
2. Able to give informed consent
3. Able to assess pain using a verbal rating scale
4. Assesssed to be medically stable so that life expectancy exceeds 2 weeks as assessed by recruiting anesthesiologist
Exclusion criteria: 1. Allergy to amide local anesthetics
2. Operating surgeon unable to insert the catheter as defined in the protocol
3. Planned epidural postoperative pain management
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain after amputation above knee
Signs and Symptoms
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Intervention(s)
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Continuous peripheral infusion of local anesthetic ropivacaine for 72 hours through two catheters, placed in the sciathic nerve sheath and under the amputation wound. The randomisation was done with computer-generated randomisation list on random.org, in blocks of ten patients. It was done by a person who is not working with the study otherwise. The follow-up is done by a study nurse who contacts the patients by a telephone call on 1, 3 and 12 months after the operation.
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Primary Outcome(s)
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Pain on the amputated limb 1-5 days after the operation assessed on VRS 0-4.
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Secondary Outcome(s)
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1. Pain on the amputated limb 1,3 and 12 months after the operation and amputation phantom limb pain 1-5 days after the operation and 1, 3 and 12 months after the operation on VRS 0-4
2. The consumption of opioid 1-5 days after the operation
3. Adverse events
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Secondary ID(s)
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N/A
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2013-003807-20
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Source(s) of Monetary Support
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Helsinki University Hospital (Finland)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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