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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative; Spinal Stenosis

Treatments: Drug: Buprenorphine; Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT02416804

BTDS_001

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

69 participants in 2 patient groups

Buprenorphine

Experimental group

Description:

Buprenorphine group : They will apply 3 days after the spine operation.

Treatment:

Drug: Buprenorphine

Tramadol

Active Comparator group

Description:

Tramadol group : They will take a pill of tramadol analgesics.

Treatment:

Drug: Tramadol