Opioid Tapering After Spine Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Opioid Withdrawal
• Intervention / Treatment: Procedure: Tapering plan and telephone counselling

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus, Central Denmark Region, Denmark, 8200
      • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)	0-30 days after discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Number of patients exceeding their preoperative opioid consumption measured in total Morphine Milligram Equivalents (MME)	0-365 days after discharge

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: University of Aarhus

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): October 8, 2020
• Study Completion (Actual): December 8, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Patient satisfaction; Spine surgery; Withdrawal symptoms; Opioid tapering
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 1-16-02-211-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No