NCT02416804

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

April 10, 2015

Last Update Submit

May 2, 2017

Conditions

Spinal StenosisPain, Postoperative

Keywords

buprenorphinetransdermal systemPain, postoperativeQuality of lifeSpinal stenosisPosterior lumbar fusion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Buprenorphine

EXPERIMENTAL

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

Drug: Buprenorphine

Tramadol

ACTIVE COMPARATOR

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

Drug: Tramadol

Interventions

BuprenorphineDRUG

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

Also known as: Norspan
Buprenorphine
TramadolDRUG

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

Also known as: Zytram
Tramadol

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults over 20 years
  • taking the lumbar spinal surgery : single-level, posterior fusion
  • stay in hospital more than 2 days after operation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

  • Kim HJ, Ahn HS, Nam Y, Chang BS, Lee CK, Yeom JS. Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial. Eur Spine J. 2017 Nov;26(11):2961-2968. doi: 10.1007/s00586-017-5213-5. Epub 2017 Jul 20.

    PMID: 28730328DERIVED

MeSH Terms

Conditions

Spinal StenosisPain, Postoperative

Interventions

BuprenorphineTramadol

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Ho-Joong Kim, MD

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 15, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

February 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

KR(1)