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

NCT ID: NCT02575664

Last Updated: 2015-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Osteoarthritis

Keywords

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Pain Arthroplasty Buprenorphine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Buprenorphine

Buprenorphine 5 microg/h/7days patch

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

Buprenorphine 5 microg/h/7 days

Placebo

Placebo patch

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo patch

Interventions

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Buprenorphine

Buprenorphine 5 microg/h/7 days

Intervention Type DRUG

Placebo

Placebo patch

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Merja Kokki

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merja Kokki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

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Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

Other Identifiers

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KUH2011-000692-14

Identifier Type: -

Identifier Source: org_study_id