Clinical trial NCT04140955: Opioid Tapering After Spine Surgery
Official title: Opioid Tapering After Spine Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Withdrawal
Postoperative Pain
Keywords: Opioid tapering
Withdrawal symptoms
Spine surgery
Patient satisfaction
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2019-10-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
timeFrame: 0-30 days after discharge
Secondary outcomes:
measure: Number of patients tapering off to zero measured in total MME
timeFrame: 0-90 days after discharge
measure: Withdrawal symptoms (yes/no) during opioid tapering
timeFrame: 0-30 days after discharge
measure: Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)
timeFrame: 0-14 days after discharge
measure: Pain-related contacts to the primary and/or secondary health care system (yes/no)
timeFrame: 0-14 days after discharge
measure: Number of patients tapering off to zero measured in total MME
timeFrame: 0-365 days after discharge
measure: Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
timeFrame: 0-365 days after discharge
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Denmark Region
Study officials:
References:
citation: 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.
citation: 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.