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Completed

NCT Number: NCT04140955

Opioid Tapering After Spine Surgery

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tapering plan and telephone counselling

Procedure

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 outcomes

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

    Time frame: 0-30 days after discharge

Secondary outcomes

  1. Number of patients tapering off to zero measured in total MME

    Time frame: 0-90 days after discharge

  2. Withdrawal symptoms (yes/no) during opioid tapering

    Time frame: 0-30 days after discharge

  3. Patient satisfaction (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied)

    Time frame: 0-14 days after discharge

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

    Time frame: 0-14 days after discharge

  5. Number of patients tapering off to zero measured in total MME

    Time frame: 0-365 days after discharge

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

    Time frame: 0-365 days after discharge

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

Opioid Tapering After Spine Surgery: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 28, 2019
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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