Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty
lonkkalaasta
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Aug 2012
Longer than P75 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 9, 2015
CompletedFirst Posted
Study publicly available on registry
October 15, 2015
CompletedDecember 29, 2015
December 1, 2015
3.2 years
October 9, 2015
December 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain relief
Brief pain inventory
time from drug patch administration up to five weeks
Prolonged pain after arthroplastic surgery
Brief pain inventory
from time from drug patch administration up to one year
Study Arms (2)
Buprenorphine
EXPERIMENTALBuprenorphine 5 microg/h/7days patch
Placebo
PLACEBO COMPARATORPlacebo patch
Interventions
Eligibility Criteria
You may qualify if:
- no pregnancy/lactation, reliable contraception before menopause
- elective knee or hip arthroplasty surgery
- BMI (=body mass index) 18-35 kg/m2
- obtained informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuopio University Hospitallead
- University of Eastern Finlandcollaborator
Study Sites (1)
Kuopio University Hospital
Kuopio, Northern Savonia, 70029, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merja Kokki, MD, PhD
Kuopio University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 9, 2015
First Posted
October 15, 2015
Study Start
August 1, 2012
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
December 29, 2015
Record last verified: 2015-12