---
title: Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery
nct_id: NCT02416804
overall_status: COMPLETED
phase: PHASE4
sponsor: Seoul National University Hospital
study_type: INTERVENTIONAL
primary_condition: Spinal Stenosis
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02416804.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02416804"
ct_last_update_post_date: 2017-05-03
last_seen_at: "2026-05-12T06:41:12.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Postoperative Analgesia With Buprenorphine for Postoperative Pain Control and Quality of Life After Spinal Surgery

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

**NCT ID:** [NCT02416804](https://clinicaltrials.gov/study/NCT02416804)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 69
- **Lead Sponsor:** Seoul National University Hospital
- **Conditions:** Spinal Stenosis, Pain, Postoperative
- **Start Date:** 2015-01
- **Completion Date:** 2017-02
- **CT.gov Last Update:** 2017-05-03

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Buprenorphine** (EXPERIMENTAL) — Buprenorphine group : They will apply 3 days after the spine operation.
- **Tramadol** (ACTIVE_COMPARATOR) — Tramadol group : They will take a pill of tramadol analgesics.

## Interventions

- **Buprenorphine** (DRUG) — 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** (DRUG) — Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -\> 200 mg/d -\> 250 mg/d -\> 300 mg/d

## Primary Outcomes

- **Pain intensity score : pain NRS scale** _(time frame: 3 months)_ — We will estimate pain NRS scale at 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months postoperatively.

## Locations (1)

- Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.seoul national university bundang hospital|seongnam-si|gyeonggi-do|south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02416804.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02416804*  
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