Back to resultsPostoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery
Primary Purpose
Spinal Stenosis, Pain, Postoperative
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Buprenorphine
Tramadol
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis focused on measuring buprenorphine, transdermal system, Pain, postoperative, Quality of life, Spinal stenosis, Posterior lumbar fusion
Eligibility 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
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Buprenorphine
Tramadol
Arm Description
Buprenorphine group : They will apply 3 days after the spine operation.
Tramadol group : They will take a pill of tramadol analgesics.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02416804
First Posted
April 10, 2015
Last Updated
May 2, 2017
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02416804
Brief Title
Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery
Official Title
Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis, Pain, Postoperative
Keywords
buprenorphine, transdermal system, Pain, postoperative, Quality of life, Spinal stenosis, Posterior lumbar fusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buprenorphine
Arm Type
Experimental
Arm Description
Buprenorphine group : They will apply 3 days after the spine operation.
Arm Title
Tramadol
Arm Type
Active Comparator
Arm Description
Tramadol group : They will take a pill of tramadol analgesics.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
Norspan
Intervention Description
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
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Zytram
Intervention Description
Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -> 200 mg/d -> 250 mg/d -> 300 mg/d
Primary Outcome Measure Information:
Title
Pain intensity score : pain NRS scale
Description
We will estimate pain NRS scale at 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months postoperatively.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho-Joong Kim, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28730328
Citation
Kim HJ, Ahn HS, Nam Y, Chang BS, Lee CK, Yeom JS. Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial. Eur Spine J. 2017 Nov;26(11):2961-2968. doi: 10.1007/s00586-017-5213-5. Epub 2017 Jul 20.
Results Reference
derived
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Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery
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