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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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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02416804 |
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Date of registration:
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10/04/2015 |
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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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Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery
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Scientific title:
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Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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69 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02416804 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Ho-Joong Kim, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Bundang Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adults over 20 years
- taking the lumbar spinal surgery : single-level, posterior fusion
- stay in hospital more than 2 days after operation
Exclusion Criteria:
- pregnancy or breast-feeding
- allergy or contraindication to buprenorphine
- patient with decreased lung function
- patient with taking MAO inhibitor or anticonvulsant
- patient with brain lesion, or severe liver disease
- dependence in opioid drugs
- taking muscle relaxant or tranquilizer
- patient had taken buprenorphine preoperatively
- taking strong opioids before enrolling the study
- another severe source of pain except lumbar spine
- severe cardiovascular, pulmonary, or renal compromised patients
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spinal Stenosis
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Pain, Postoperative
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Intervention(s)
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Drug: Tramadol
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Drug: Buprenorphine
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Primary Outcome(s)
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Pain intensity score : pain NRS scale
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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