Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Stenosis; Pain, Postoperative
Intervention: Buprenorphine (Drug); Tramadol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s): Ho-Joong Kim, MD, Study Director, Affiliation: Seoul National University Bundang Hospital
Overall contact: Ho-Joong Kim, MD, Phone: +82-31-787-7202, Email: oshjkim@gmail.com
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.
Clinical Details
Official title: Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Pain intensity score : pain NRS scale
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Ho-Joong Kim, MD, Phone: +82-31-787-7202, Email: oshjkim@gmail.com
Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, Korea, Republic of; Recruiting Ho-Joong Kim, MD, Phone: +82-31-787-7202, Email: oshjkim@gmail.com Ho-Joong Kim, MD, Principal Investigator
Additional Information
Starting date: February 2015
Last updated: April 14, 2015
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