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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


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


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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