Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery
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|ClinicalTrials.gov Identifier: NCT02416804|
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : May 3, 2017
Major purpose of this research is to evaluate the effect and usefulness of Buprenorphine transdermal system (MTDS) among the patients with lumbar spinal disease who was performed the single-level posterior lumbar fusion.
After surgery, all the patients apply the patient-controlled analgesia. After three days of surgery, patients are divided into two groups.Group A is an experimental group that administer the BTDS after surgery, and Group B is a control group that take tramadol analgesics. If the patient's pain score exceeds the NRS 4, they can take the additional rescue medicine, acetaminophen.
After the surgery, patient's pain score and quality of life would be recorded sequentially. The time of recording is postoperative 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months, respectively.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Stenosis Pain, Postoperative||Drug: Buprenorphine Drug: Tramadol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||February 2017|
Buprenorphine group : They will apply 3 days after the spine operation.
Buprenorphine transdermal patch Initial : 5 μg/hr Sequential increasing of dose : 5 μg/hr -> 10 μg/hr -> 15 (5+10) μg/hr -> 20 μg/hr
Other Name: Norspan
Active Comparator: Tramadol
Tramadol group : They will take a pill of tramadol analgesics.
Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -> 200 mg/d -> 250 mg/d -> 300 mg/d
Other Name: Zytram
- Pain intensity score : pain NRS scale [ Time Frame: 3 months ]We will estimate pain NRS scale at 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months postoperatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416804
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi-do, Korea, Republic of, 463-707|
|Study Director:||Ho-Joong Kim, MD||Seoul National University Bundang Hospital|