Opioid Tapering After Spine Surgery

Aarhus University Hospital

Status: Completed

Conditions: Postoperative Pain; Opioid Withdrawal

Treatments: Procedure: Tapering plan and telephone counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT04140955

1-16-02-211-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Tapering plan and telephone counselling

Experimental group

Description:

Patients receive an individually customized tapering plan at discharge and telephone counselling 5-7 days after discharge.

Treatment:

Procedure: Tapering plan and telephone counselling

Control group

No Intervention group

Description:

Patients receive standard care and treatment, i.e. no tapering plan or telephone counselling.