Postoperative Pain Clinical Trial
Official title:
Opioid Tapering After Spine Surgery: a Randomized Controlled Trial
Verified date | September 2022 |
Source | Aarhus University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The effect of a tapering plan combined with telephone counselling to assist patients in opioid tapering after surgery remains unexplored. A prospective, randomized controlled trial investigating the effect of a tapering plan in combination with telephone counselling in patients scheduled for spine surgery on a degenerative basis is therefore conducted.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 8, 2020 |
Est. primary completion date | October 8, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Daily opioid consumption at least 14 days before surgery - Planned degenerative cervical, thoracic or lumbar spine surgery Exclusion Criteria: - Severe physical co-morbidity or inability to participate (dementia, language problems or mental illness) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | Central Denmark Region |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital | University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME) | 0-30 days after discharge | ||
Secondary | Number of patients tapering off to zero measured in total MME | 0-90 days after discharge | ||
Secondary | Withdrawal symptoms (yes/no) during opioid tapering | 0-30 days after discharge | ||
Secondary | Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied) | 0-14 days after discharge | ||
Secondary | Pain-related contacts to the primary and/or secondary health care system (yes/no) | 0-14 days after discharge | ||
Secondary | Number of patients tapering off to zero measured in total MME | 0-365 days after discharge | ||
Secondary | Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME) | 0-365 days after discharge |
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