Opioid Withdrawal, Postoperative Pain
Conditions
Keywords
Opioid tapering, Withdrawal symptoms, Spine surgery, Patient satisfaction
Brief summary
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
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.
Interventions
PROCEDURETapering plan and telephone counselling
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.
Sponsors
University of Aarhus
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME) | 0-30 days after discharge |
Secondary
| Measure | 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 exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME) | 0-365 days after discharge |
Countries
Denmark
Outcome results
None listed