Opioid Tapering After Spine Surgery

Postoperative Pain Clinical Trial

Official title:

Opioid Tapering After Spine Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04140955
• Other study ID #: 1-16-02-211-19
• Status: Completed
• Phase: N/A
• Start date: October 22, 2019
• Est. completion date: December 8, 2020

Study information

• Verified date: September 2022
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 8, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Opioid Withdrawal
• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Denmark Region

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)		0-30 days after discharge
Secondary	Number of patients tapering off to zero measured in total MME		0-90 days after discharge
Secondary	Withdrawal symptoms (yes/no) during opioid tapering		0-30 days after discharge
Secondary	Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)		0-14 days after discharge
Secondary	Pain-related contacts to the primary and/or secondary health care system (yes/no)		0-14 days after discharge
Secondary	Number of patients tapering off to zero measured in total MME		0-365 days after discharge
Secondary	Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)		0-365 days after discharge