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

Pain, Postoperative Clinical Trial

Official title:

Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416804
• Other study ID #: BTDS_001
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2015
• Last updated: May 2, 2017
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months