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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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11 February 2019 |
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Main ID: |
ISRCTN23704397 |
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Date of registration:
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02/07/2014 |
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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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Could treatment with prolonged peripheral nerve block reduce phantom limb pain on lower extremity amputation?
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Scientific title:
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Could treatment with prolonged peripheral nerve block reduce phantom limb pain on lower extremity amputation? A randomized controlled study |
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Date of first enrolment:
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19/05/2014 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN23704397 |
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Study type:
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Interventional |
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Study design:
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Randomized controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Anna
Unneby |
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Address:
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Umeå University Hospital
Department of Orthopedics
901 85
Umeå
Sweden |
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Telephone:
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- |
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Email:
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unneby85@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Age 65 years or older
2. With a decision from the responsible orthopedic physician that a transtibial amputation of one or both legs is necessary
3. Residents to the county of Norrland University Hospital
Exclusion criteria: Younger than age 65
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Transtibial amputation of one or both legs, phantom limb pain
Musculoskeletal Diseases
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Intervention(s)
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Once the doctor has decided on amputation he/she will contact the research nurse, which in turn will provide written and verbal information about the study to the patient for approval of participation. Then the patient is randomized to a treatment group by drawing lots. A non-transparent envelope is opened containing information about the study and consent forms to be signed. A person who is not included in the study mixes the envelopes with the two treatment options, then placed them in a single junction of the department where the study will be conducted. The person who gives the information to the patient takes the top envelope in the pile.
1. The intervention group receives a peripheral nerve block of the ischiadic nerve by placing a catheter just above the back of the knee using ultrasound adjacent with the ischiadic nerve. This is done in conjunction with the amputation. Postoperatively local anesthetic of Chirocaine 2.5 mg / ml, 20 ml is administered as bolus into the catheter at intervals of 4-6 hours/day. Treatment with peripheral nerve blockade continues until the patient is discharged.
2. The control group receive EDA (epidural) pain management which is currently the usual pain treatment for amputations.
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Primary Outcome(s)
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1. Phantom pain
2. Phantom sensation
Measured from the day of surgery (six times a day, for at least 1 week), from day 7 until discharge 3 times a day and at 3, 6 and 12 months.
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Secondary Outcome(s)
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1. Quality of life
2. Subjected well-being [Philadelphia Geriatric Center Morale Scale (PGCMS)]
3. Depression [15-item Geriatric Depression Scale (GDS-15)]
Measured from the day of surgery (six times a day, for at least 1 week), from day 7 until discharge 3 times a day and at 3, 6 and 12 months.
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Source(s) of Monetary Support
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County Council of Västerbotten (Sweden), Dementia Foundation (Sweden)
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Ethics review
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Status:
Approval date:
Contact:
Ethical Committee of the Faculty of Medicine at Umeå University, 23/01/2014, ref: 2013-413-31M
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/06/2017 |
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URL:
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