NCT04140955

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

October 22, 2019

Last Update Submit

September 30, 2022

Conditions

Opioid WithdrawalPostoperative Pain

Keywords

Opioid taperingWithdrawal symptomsSpine surgeryPatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)

    0-30 days after discharge

Secondary Outcomes (6)

  • Number of patients tapering off to zero measured in total MME

    0-90 days after discharge

  • Withdrawal symptoms (yes/no) during opioid tapering

    0-30 days after discharge

  • Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)

    0-14 days after discharge

  • Pain-related contacts to the primary and/or secondary health care system (yes/no)

    0-14 days after discharge

  • Number of patients tapering off to zero measured in total MME

    0-365 days after discharge

  • +1 more secondary outcomes

Study Arms (2)

Tapering plan and telephone counselling

EXPERIMENTAL

Patients receive an individually customized tapering plan at discharge and telephone counselling 5-7 days after discharge.

Procedure: Tapering plan and telephone counselling

Control group

NO INTERVENTION

Patients receive standard care and treatment, i.e. no tapering plan or telephone counselling.

Interventions

Tapering plan and telephone counsellingPROCEDURE

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.

Tapering plan and telephone counselling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Daily opioid consumption at least 14 days before surgery
  • Planned degenerative cervical, thoracic or lumbar spine surgery

You may not qualify if:

  • Severe physical co-morbidity or inability to participate (dementia, language problems or mental illness)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 34433772DERIVED

  • 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.

    PMID: 32157678DERIVED

MeSH Terms

Conditions

Pain, PostoperativeSubstance Withdrawal SyndromePatient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Student

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 28, 2019

Study Start

October 22, 2019

Primary Completion

October 8, 2020

Study Completion

December 8, 2020

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

DK(1)