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

Study Overview
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Brief Summary
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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.

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

Conditions
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Spinal Stenosis, Pain, Postoperative

Intervention / Treatment
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* Drug: Buprenorphine
* Drug: Tramadol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buprenorphine<br>Buprenorphine group : They will apply 3 days after the spine operation. | Drug: Buprenorphine<br>* 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<br>* Other names: Norspan;|
| Active Comparator: Tramadol<br>Tramadol group : They will take a pill of tramadol analgesics. | Drug: Tramadol<br>* Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -> 200 mg/d -> 250 mg/d -> 300 mg/d<br>* Other names: Zytram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity score : pain NRS scale | We will estimate pain NRS scale at 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months postoperatively. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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buprenorphine, transdermal system, Pain, postoperative, Quality of life, Spinal stenosis, Posterior lumbar fusion