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

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ClinicalTrials.gov Identifier: NCT02416804
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Jin S. Yeom, 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.


Condition or disease Intervention/treatment Phase
Spinal Stenosis Pain, Postoperative Drug: Buprenorphine Drug: Tramadol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery
Actual Study Start Date : January 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Buprenorphine
Buprenorphine group : They will apply 3 days after the spine operation.
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
Other Name: Norspan

Active Comparator: Tramadol
Tramadol group : They will take a pill of tramadol analgesics.
Drug: Tramadol
Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -> 200 mg/d -> 250 mg/d -> 300 mg/d
Other Name: Zytram




Primary Outcome Measures :
  1. Pain intensity score : pain NRS scale [ Time Frame: 3 months ]
    We will estimate pain NRS scale at 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months postoperatively.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416804


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Ho-Joong Kim, MD Seoul National University Bundang Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jin S. Yeom, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02416804     History of Changes
Other Study ID Numbers: BTDS_001
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Jin S. Yeom, Seoul National University Hospital:
buprenorphine
transdermal system
Pain, postoperative
Quality of life
Spinal stenosis
Posterior lumbar fusion

Additional relevant MeSH terms:
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Pain, Postoperative
Spinal Stenosis
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Buprenorphine
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists