NCT04140955

Opioid Tapering After Spine Surgery

Opioid Tapering After Spine Surgery: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid Withdrawal
• Postoperative Pain

Interventions

Type	Name	Description
PROCEDURE	Tapering 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.

Timeline

• Start date: 2019-10-22
• Primary completion: 2020-10-08
• Completion: 2020-12-08
• First posted: 2019-10-28
• Last updated: 2022-10-03

Locations

1 site across 1 country: Denmark