Opioid WithdrawalNCT04140955
Opioid Tapering After Spine Surgery
A study testing Tapering plan and telephone counselling in people with Opioid Withdrawal and Postoperative Pain, run by Aarhus University Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Withdrawal, Postoperative Pain
- What is being tested?
- Tapering plan and telephone counselling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Oct 2019to 8 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Daily opioid consumption at least 14 days before surgery
- Planned degenerative cervical, thoracic or lumbar spine surgery
Who cannot join
- Severe physical co-morbidity or inability to participate (dementia, language problems or mental illness)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Opioid Tapering After Spine Surgery: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Tapering plan and telephone counselling
- Keywords
- Opioid tapering, Withdrawal symptoms, Spine surgery, Patient satisfaction
- Medical subject headings
- Pain, Postoperative, Substance Withdrawal Syndrome, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapering plan and telephone counsellingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Tapering plan and telephone counselling | Experimental | Patients receive an individually customized tapering plan at discharge and telephone counselling 5-7 days after discharge. Receives: Procedure: Tapering plan and telephone counselling |
| Control group | No intervention | Patients receive standard care and treatment, i.e. no tapering plan or telephone counselling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Measured: 0-30 days after discharge
Secondary outcomes (6)
Number of patients tapering off to zero measured in total MME
Measured: 0-90 days after discharge
Withdrawal symptoms (yes/no) during opioid tapering
Measured: 0-30 days after discharge
Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)
Measured: 0-14 days after discharge
Pain-related contacts to the primary and/or secondary health care system (yes/no)
Measured: 0-14 days after discharge
Number of patients tapering off to zero measured in total MME
Measured: 0-365 days after discharge
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Measured: 0-365 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start22 Oct 2019
- Primary completion8 Oct 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid WithdrawalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Peter Gaarsdal Uhrbrand, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140955
- Sponsor's protocol ID
- 1-16-02-211-19
- Status last verified
- Sep 2022
- First submitted
- 22 Oct 2019
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34433772Uhrbrand 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.
PubMed 32157678
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Tapering After Spine Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04140955
- Acronym / sponsor ID
- 1-16-02-211-19
- Conditions
- Opioid Withdrawal, Postoperative Pain
- Keywords
- Opioid tapering, Withdrawal symptoms, Spine surgery, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 28 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tapering plan and telephone counselling | Experimental | Procedure: Tapering plan and telephone counsellingPatients receive an individually customized tapering plan at discharge and telephone counselling 5-7 days after discharge. |
| Control group | No intervention | –Patients receive standard care and treatment, i.e. no tapering plan or telephone counselling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Daily opioid consumption at least 14 days before surgery
- Planned degenerative cervical, thoracic or lumbar spine surgery
Key exclusion criteria (1 listed)
- Severe physical co-morbidity or inability to participate (dementia, language problems or mental illness)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapering plan and telephone counsellingBefore 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. | Procedure or surgery | Tapering plan and telephone counselling |
Primary outcome
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Time frame: 0-30 days after discharge
6 secondary outcomes
Number of patients tapering off to zero measured in total MME
Time frame: 0-90 days after discharge
Withdrawal symptoms (yes/no) during opioid tapering
Time frame: 0-30 days after discharge
Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)
Time frame: 0-14 days after discharge
Pain-related contacts to the primary and/or secondary health care system (yes/no)
Time frame: 0-14 days after discharge
Number of patients tapering off to zero measured in total MME
Time frame: 0-365 days after discharge
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)
Time frame: 0-365 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
- Derived from this study: PubMed 34433772Uhrbrand 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.
- Derived from this study: PubMed 32157678Uhrbrand 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.
Related trials for Opioid Withdrawal
Active, not recruitingPhase 1/2
Sublingual Dexmedetomidine for Treating Opioid Withdrawal
Opioid Use Disorder, Opioid Withdrawal
RecruitingPhase 2
A Study of Cebranopadol for Opioid Withdrawal Symptoms in Adults With Chronic Pain
Chronic Pain, Pain
Not yet recruitingPhase 1/2
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
Opioid Use Disorder, Opioid Withdrawal
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
RecruitingObservational study
Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
Opioid Withdrawal, Opioid Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tapering plan and telephone counselling in people with Opioid Withdrawal and Postoperative Pain, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME) (time frame: 0-30 days after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04140955, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022; AzTrials last refreshed its copy on 29 Oct 2026.