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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04140955
Other study ID # 1-16-02-211-19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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