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Completed

NCT Number: NCT02575664

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

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.

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Key information

Conditions

Pain Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

Buprenorphine 5 microg/h/7 days

Placebo

Drug

Placebo patch

Primary outcomes

  1. Pain relief

    Time frame: time from drug patch administration up to five weeks

    Brief pain inventory

  2. Prolonged pain after arthroplastic surgery

    Time frame: from time from drug patch administration up to one year

    Brief pain inventory

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • University of Eastern Finland

Registry information

Acronym: lonkkalaasta

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2015
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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