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Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty (lonkkalaasta)

Primary Purpose

Pain, Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Buprenorphine
Placebo
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Arthroplasty, Buprenorphine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • no pregnancy/lactation, reliable contraception before menopause
  • elective knee or hip arthroplasty surgery
  • BMI (=body mass index) 18-35 kg/m2
  • obtained informed consent

Exclusion Criteria:

  • buprenorphine medication

  • allergy to study drugs• ikä < 18 tai >75 years

    • BMI <18 tai>35 kg/m2
    • weight below 50 kg
    • Other contraindication for the study drug

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Buprenorphine

Placebo

Arm Description

Buprenorphine 5 microg/h/7days patch

Placebo patch

Outcomes

Primary Outcome Measures

Pain relief
Brief pain inventory
Prolonged pain after arthroplastic surgery
Brief pain inventory

Secondary Outcome Measures

Full Information

First Posted
October 9, 2015
Last Updated
December 25, 2015
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT02575664
Brief Title
Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty
Acronym
lonkkalaasta
Official Title
Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1 -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up to two-fold duration of action and it is approximately 30-fold more potent when compared to morphine. Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low dose patches are recommended for treatment of moderate pain for example osteoarthritis pain. It is known that well treated pain even preoperatively may prevent prolonged postsurgical pain. In the present study the effects of low dose buprenorphine on postoperative pain and recovery were assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Osteoarthritis
Keywords
Pain, Arthroplasty, Buprenorphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Buprenorphine
Arm Type
Experimental
Arm Description
Buprenorphine 5 microg/h/7days patch
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo patch
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Intervention Description
Buprenorphine 5 microg/h/7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo patch
Primary Outcome Measure Information:
Title
Pain relief
Description
Brief pain inventory
Time Frame
time from drug patch administration up to five weeks
Title
Prolonged pain after arthroplastic surgery
Description
Brief pain inventory
Time Frame
from time from drug patch administration up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: no pregnancy/lactation, reliable contraception before menopause elective knee or hip arthroplasty surgery BMI (=body mass index) 18-35 kg/m2 obtained informed consent Exclusion Criteria: buprenorphine medication allergy to study drugs• ikä < 18 tai >75 years BMI <18 tai>35 kg/m2 weight below 50 kg Other contraindication for the study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merja Kokki, MD, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Northern Savo
ZIP/Postal Code
70029
Country
Finland

12. IPD Sharing Statement

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Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty

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