drugset / Trial / NCT02416804

Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery

NCT02416804

Phase 4 Completed 69 enrolled Seoul National University Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2015-01
Primary completion
2016-07
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 20 ug Other
Comparator Tramadol Other / unclassified 300 mg Oral

Indications