NCT02416804

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

Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Stenosis
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Buprenorphine	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
DRUG	Tramadol	Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -\> 200 mg/d -\> 250 mg/d -\> 300 mg/d

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-07-01
• Completion: 2017-02-01
• First posted: 2015-04-15
• Last updated: 2017-05-03

Locations

1 site across 1 country: South Korea