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

Pain Clinical Trial

— lonkkalaasta  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575664
• Other study ID #: KUH2011-000692-14
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2015
• Last updated: December 25, 2015
• Start date: August 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Drug:
• Buprenorphine
Buprenorphine 5 microg/h/7 days
• Placebo
Placebo patch

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Northern Savo

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	Brief pain inventory	time from drug patch administration up to five weeks	No
Primary	Prolonged pain after arthroplastic surgery	Brief pain inventory	from time from drug patch administration up to one year	Yes