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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-02-28

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.

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Detailed Description

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Conditions

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Spinal Stenosis Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Buprenorphine

Buprenorphine group : They will apply 3 days after the spine operation.

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

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

Tramadol

Tramadol group : They will take a pill of tramadol analgesics.

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -\> 200 mg/d -\> 250 mg/d -\> 300 mg/d

Interventions

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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

Intervention Type DRUG

Tramadol

Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -\> 200 mg/d -\> 250 mg/d -\> 300 mg/d

Intervention Type DRUG

Other Intervention Names

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Norspan Zytram

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No