Opioid Tapering After Spine Surgery
Primary Purpose
Opioid Withdrawal, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Tapering plan and telephone counselling
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Withdrawal focused on measuring Opioid tapering, Withdrawal symptoms, Spine surgery, Patient satisfaction
Eligibility Criteria
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)
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tapering plan and telephone counselling
Control group
Arm Description
Patients receive an individually customized tapering plan at discharge and telephone counselling 5-7 days after discharge.
Patients receive standard care and treatment, i.e. no tapering plan or telephone counselling.
Outcomes
Primary Outcome Measures
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Secondary Outcome Measures
Number of patients tapering off to zero measured in total MME
Withdrawal symptoms (yes/no) during opioid tapering
Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)
Pain-related contacts to the primary and/or secondary health care system (yes/no)
Number of patients tapering off to zero measured in total MME
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Full Information
NCT ID
NCT04140955
First Posted
October 22, 2019
Last Updated
September 30, 2022
Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT04140955
Brief Title
Opioid Tapering After Spine Surgery
Official Title
Opioid Tapering After Spine Surgery: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
October 8, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Withdrawal, Postoperative Pain
Keywords
Opioid tapering, Withdrawal symptoms, Spine surgery, Patient satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tapering plan and telephone counselling
Arm Type
Experimental
Arm Description
Patients receive an individually customized tapering plan at discharge and telephone counselling 5-7 days after discharge.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients receive standard care and treatment, i.e. no tapering plan or telephone counselling.
Intervention Type
Procedure
Intervention Name(s)
Tapering plan and telephone counselling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Time Frame
0-30 days after discharge
Secondary Outcome Measure Information:
Title
Number of patients tapering off to zero measured in total MME
Time Frame
0-90 days after discharge
Title
Withdrawal symptoms (yes/no) during opioid tapering
Time Frame
0-30 days after discharge
Title
Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)
Time Frame
0-14 days after discharge
Title
Pain-related contacts to the primary and/or secondary health care system (yes/no)
Time Frame
0-14 days after discharge
Title
Number of patients tapering off to zero measured in total MME
Time Frame
0-365 days after discharge
Title
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Time Frame
0-365 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
State/Province
Central Denmark Region
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
34433772
Citation
Uhrbrand P, Rasmussen MM, Haroutounian S, Nikolajsen L. Shared decision-making approach to taper postoperative opioids in spine surgery patients with preoperative opioid use: a randomized controlled trial. Pain. 2022 May 1;163(5):e634-e641. doi: 10.1097/j.pain.0000000000002456.
Results Reference
derived
PubMed Identifier
32157678
Citation
Uhrbrand P, Phillipsen A, Rasmussen MM, Nikolajsen L. Opioid tapering after spine surgery: Protocol for a randomized controlled trial. Acta Anaesthesiol Scand. 2020 Aug;64(7):1021-1024. doi: 10.1111/aas.13576. Epub 2020 Mar 26.
Results Reference
derived
Learn more about this trial
Opioid Tapering After Spine Surgery
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