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Preoperative Opioid Tapering Before Spine Surgery

ConditionsOpioid Consumption, PostoperativePain After SurgeryOpioid Dependency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University

About this trial

This is a pilot study in which patients taking opioids chronically who are scheduled for spine surgery at least 4 weeks in advance will be randomly assigned to one of two groups: opioid tapering with education alone or opioid tapering with education plus cognitive behavioral therapy (CBT). The primary objective is to determine the proportion of each group that is successful in achieving their opioid tapering goals by the time of surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

at least 18 years old

scheduled for major spine surgery (i.e. at least 1 level of fusion) with hospital admission of at least one night

scheduled for spine surgery at least 4 weeks ahead of time

takes between 40 and 200 oral morphine equivalents daily

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Opioid tapering with CBT and education

    Other intervention

    Patients in the opioid tapering plus CBT group will set up an initial meeting with the pain physician within a few days of enrollment to set the tapering schedule. They will also have two CBT appointments set up to complete via telemedicine during the time between enrollment and surgery.

  • Opioid tapering with education alone

    Other intervention

    Patients in this group will be instructed to continue their opioids at the same doses and frequencies they were taking up through the day of surgery. They will set up an initial meeting within a few days of enrollment with the chronic pain physician to determine the tapering schedule which will occur over 4 weeks or more leading into surgery. The patient and pain physician will collectively agree on a tapering schedule.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Opioid tapering with Cognitive Behavioral Therapy (CBT) and educationActive comparator 1 intervention
Group B: Opioid tapering with education aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

proportion that achieved opioid tapering goal

Achievement of the opioid tapering goal for each patient will be assessed on day of surgery and will be based on average daily OMEs taken during the three days before surgery. The opioid tapering goal will be made on the initial visit with the study pain physician and will be specific to each patient.

Time frame
Perioperative prior to surgery (postoperative day 0)

Secondary outcomes

1

Brief Pain Inventory

Brief Pain Inventory is a validated pain assessment tool that measures pain severity and its effects on daily function.

Time frame
Baseline, weeks 1-4 before surgery, day of surgery (postoperative day 0), postoperative days 1-3, and postoperative days 30, 90, 180 and 365.
2

Clinical Opiate Withdrawal Scale

Standardized assessment of opioid withdrawal

Time frame
Baseline, once weekly on weeks 1-4 prior to surgery, day of surgery (postoperative day 0), postoperative day 1, and postoperative days 30, 90, 180, and 365.
3

Patient Health Questionnaire-9

Depression screening

Time frame
Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365
4

Generalized Anxiety Disorder-2

Standardized generalized anxiety screening

Time frame
Baseline

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Thomas Jefferson University HospitalRecruiting19107, Philadephia, PennsylvaniaUnited StatesUnited States

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

Source ClinicalTrials.gov
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