A Preemptive Epidural Ropivacaine for Postoperative Pain Relief in Degenerative Lumbar Spine Surgery
NCT ID: NCT01117610
Last Updated: 2010-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2010-05-31
2011-04-30
Brief Summary
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Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation.
Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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epidural injection (group I)
patients in Group I will receive epidural injection of 0.1% ropivacaine 10 ml before skin incision.
Ropivacaine (epidural injection)
patient in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
epidural injection group (group C)
control group will receive no medication preoperatively and during operation
Placebo (one of medication)
patients in Group C will receive none of medication preoperatively and intraoperatively
Interventions
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Placebo (one of medication)
patients in Group C will receive none of medication preoperatively and intraoperatively
Ropivacaine (epidural injection)
patient in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* reoperation
* mental change
* allergy to local anesthetics
18 Years
65 Years
ALL
No
Sponsors
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Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Responsible Party
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Chung-Ang University Hospital
Principal Investigators
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Kwang-Sup Song, M.D. & Ph.D.
Role: STUDY_DIRECTOR
ChungAng University
Hyun Kang, M.D. & Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Locations
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ChungAng University
Seoul, , South Korea
Countries
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Facility Contacts
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References
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Kang H, Jung HJ, Lee JS, Yang JJ, Shin HY, Song KS. Early postoperative analgesic effects of a single epidural injection of ropivacaine administered preoperatively in posterior lumbar interbody spinal arthrodesis: a pilot randomized controlled trial. J Bone Joint Surg Am. 2013 Mar 6;95(5):393-9. doi: 10.2106/JBJS.K.01729.
Other Identifiers
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ChungAngUH
Identifier Type: -
Identifier Source: org_study_id
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