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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02416804

Enrollment

Registered

2015-04-15

Start date

2015-01-31

Completion date

2017-02-28

Last updated

2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Spinal Stenosis

Keywords

buprenorphine, transdermal system, Pain, postoperative, Quality of life, Spinal stenosis, Posterior lumbar fusion

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.

Interventions

DRUGBuprenorphine

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

DRUGTramadol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain intensity score : pain NRS scale	3 months	We will estimate pain NRS scale at 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months postoperatively.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026