Opioid Tapering After Spine Surgery

Sponsor

Aarhus University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04140955

Collaborator

University of Aarhus (Other)

110

Enrollment

Location

Arms

13.6

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Withdrawal Postoperative Pain	Procedure: Tapering plan and telephone counselling	N/A

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

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Opioid Tapering After Spine Surgery: a Randomized Controlled Trial

Actual Study Start Date :

Oct 22, 2019

Actual Primary Completion Date :

Oct 8, 2020

Actual Study Completion Date :

Dec 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tapering plan and telephone counselling Patients receive an individually customized tapering plan at discharge and telephone counselling 5-7 days after discharge.	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.
No Intervention: Control group Patients receive standard care and treatment, i.e. no tapering plan or telephone counselling.

Arm

Intervention/Treatment

Experimental: Tapering plan and telephone counselling

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

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.

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME) [0-30 days after discharge]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus	Central Denmark Region	Denmark	8200

Sponsors and Collaborators

Aarhus University Hospital
University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Gaarsdal Uhrbrand, MD, PhD Student, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT04140955

Other Study ID Numbers:

1-16-02-211-19

First Posted:

Oct 28, 2019

Last Update Posted:

Dec 9, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peter Gaarsdal Uhrbrand, MD, PhD Student, Aarhus University Hospital

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Dec 9, 2020