Opioid Tapering After Spine Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Opioid Tapering After Spine Surgery: a Randomized Controlled Trial

Conditions
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Opioid Withdrawal, Postoperative Pain

Intervention / Treatment
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* Procedure: Tapering plan and telephone counselling


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tapering plan and telephone counselling<br>Patients receive an individually customized tapering plan at discharge and telephone counselling 5-7 days after discharge. | Procedure: Tapering plan and telephone counselling<br>* 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.<br>|
| No Intervention: Control group<br>Patients receive standard care and treatment, i.e. no tapering plan or telephone counselling. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME) |  | 0-30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid tapering, Withdrawal symptoms, Spine surgery, Patient satisfaction