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

Phase 4

Completed

• Conditions: Spinal Stenosis; Pain, Postoperative
• Interventions: Drug: Tramadol; Drug: Buprenorphine

• Registration Number: NCT02416804
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-15
• Primary Completion: 2016-07
• Study Completion: 2017-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol	Tramadol	Tramadol group : They will take a pill of tramadol analgesics.
Buprenorphine	Buprenorphine	Buprenorphine group : They will apply 3 days after the spine operation.

Primary Outcome Measures

Name	Time	Method
Pain intensity score : pain NRS scale	3 months	We will estimate pain NRS scale at 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months postoperatively.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of