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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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.
Background with aim:
Preoperative opioid-use is one of the strongest predictors for not tapering off opioids after discharge from surgery. In qualitative studies on chronic opioid use, patients call for further help and assistance in tapering opioids. The aim of this study is to investigate the effect of receiving a tapering plan at discharge and telephone counselling one week after discharge on short and long-term opioid-use in preoperative opioid-users who undergo scheduled spine surgery.
Methods:
One-hundred and ten adult patients scheduled for spine surgery will be included in an investigator-initiated, prospective, randomized, controlled trial with two arms: an intervention arm (receiving tapering plan at discharge and telephone counselling on opioid tapering 5-7 days after discharge) or a control arm (receiving no tapering plan or telephone counselling). The study is approved by the Danish Data Protection Agency (1-16-02-211-19) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-138-19).
Hypothesis:
Our primary hypothesis is that a tapering plan and telephone counselling reduces the percentage of patients who exceed their preoperative opioid consumption from 25% to 5% one month after discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tapering plan and telephone counselling | Experimental | Patients receive an individually customized tapering plan at discharge and telephone counselling 5-7 days after discharge. |
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| Control group | No Intervention | Patients receive standard care and treatment, i.e. no tapering plan or telephone counselling. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapering plan and telephone counselling | Procedure | Before discharge, a tapering plan is made in collaboration between the patient and one of the investigators. The telephone counselling will include guidance of the patient and/or adjustments of the tapering plan if needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME) | 0-30 days after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients tapering off to zero measured in total MME | 0-90 days after discharge | |
| Withdrawal symptoms (yes/no) during opioid tapering | 0-30 days after discharge | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Central Jutland | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34433772 | Derived | Uhrbrand P, Rasmussen MM, Haroutounian S, Nikolajsen L. Shared decision-making approach to taper postoperative opioids in spine surgery patients with preoperative opioid use: a randomized controlled trial. Pain. 2022 May 1;163(5):e634-e641. doi: 10.1097/j.pain.0000000000002456. | |
| 32157678 | Derived | Uhrbrand P, Phillipsen A, Rasmussen MM, Nikolajsen L. Opioid tapering after spine surgery: Protocol for a randomized controlled trial. Acta Anaesthesiol Scand. 2020 Aug;64(7):1021-1024. doi: 10.1111/aas.13576. Epub 2020 Mar 26. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D013375 | Substance Withdrawal Syndrome |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Randomized controlled trial
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| Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied) |
| 0-14 days after discharge |
| Pain-related contacts to the primary and/or secondary health care system (yes/no) | 0-14 days after discharge |
| Number of patients tapering off to zero measured in total MME | 0-365 days after discharge |
| Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME) | 0-365 days after discharge |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |