Opioid Tapering After Spine Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain; Opioid Withdrawal
• Interventions: Procedure: Tapering plan and telephone counselling

• Registration Number: NCT04140955
• Lead Sponsor: Aarhus University Hospital

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.

Study Timeline

• Study Start: 2019-10-22
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-28
• Primary Completion: 2020-10-08
• Study Completion: 2020-12-08
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-30
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)	0-30 days after discharge

Secondary Outcome Measures

Name	Time	Method
Pain-related contacts to the primary and/or secondary health care system (yes/no)	0-14 days after discharge
Withdrawal symptoms (yes/no) during opioid tapering	0-30 days after discharge
Number of patients tapering off to zero measured in total MME	0-365 days after discharge
Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)	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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Central Denmark Region, Denmark