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

K

Kuopio University Hospital

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis
Pain

Treatments

Drug: Buprenorphine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02575664
KUH2011-000692-14

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 2 patient groups, including a placebo group

Buprenorphine
Experimental group
Description:
Buprenorphine 5 microg/h/7days patch
Treatment:
Drug: Buprenorphine
Placebo
Placebo Comparator group
Description:
Placebo patch
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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