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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
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.
Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Time frame: 0-30 days after discharge
Number of patients tapering off to zero measured in total MME
Time frame: 0-90 days after discharge
Withdrawal symptoms (yes/no) during opioid tapering
Time frame: 0-30 days after discharge
Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)
Time frame: 0-14 days after discharge
Pain-related contacts to the primary and/or secondary health care system (yes/no)
Time frame: 0-14 days after discharge
Number of patients tapering off to zero measured in total MME
Time frame: 0-365 days after discharge
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Time frame: 0-365 days after discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.