NCT Number: NCT07221786
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Philadephia, Pennsylvania, 19107, United States
Location status: Recruiting
Eric Schwenk, MD
CONTACT
Eric Schwenk, MD
PRINCIPAL_INVESTIGATOR
Jeffrey Mojica, DO
CONTACT
Jeffrey Mojica, DO
SUB_INVESTIGATOR
The perioperative period represents a particularly problematic time for opioid-dependent patients. Perioperative pain is often difficult to control, with opioid tolerance, opioid-induced hyperalgesia, and withdrawal making management a challenge. In addition to these short-term challenges, opioid-dependent patients experience poorer outcomes after surgery, including both early and late complications, emergency room visits, infections, and reoperations. Spine surgery in opioid-tolerant patients increases the risk for prolonged postoperative opioid use. This risk is in addition to the risk of prolonged opioid use that surgery itself introduces. The high prevalence of opioid use in spine patients makes spine surgery an ideal surgical model in which to study opioid tapering.
This is a randomized, controlled pilot study of 45 opioid-dependent patients undergoing spine surgery. Patients will be assigned in parallel to one of the following: 1. opioid tapering with education alone or 2. opioid tapering with education plus cognitive behavioral therapy (CBT). While all patients will meet with a pain physician to design a personalized tapering program, the CBT group will receive two CBT sessions prior to surgery. Pain, depression, anxiety, and opioid withdrawal will be assessed throughout the month prior to surgery and managed appropriately. Opioid use at the time of surgery will be assessed along with pain and depression and anxiety. Hospital outcomes, including pain, opioid use, quality of recovery, and postoperative complications, will be measured. Patients will be followed upon discharge by a chronic pain physician and patients assigned to CBT will receive one additional session after surgery. All patients will also be assessed via telephone call or Zoom at 30, 90, 180, and 365 days for pain, function, and opioid use.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
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.
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.
Time frame: Perioperative prior to surgery (postoperative day 0)
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: Baseline, weeks 1-4 before surgery, day of surgery (postoperative day 0), postoperative days 1-3, and postoperative days 30, 90, 180 and 365.
Brief Pain Inventory is a validated pain assessment tool that measures pain severity and its effects on daily function.
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.
Standardized assessment of opioid withdrawal
Time frame: Baseline, weeks 1-4 prior to surgery, and postoperative days 30, 90, 180, and 365
Depression screening
Time frame: Baseline
Standardized generalized anxiety screening
Time frame: Screening period
This is a suicide risk screening tool
Time frame: Postoperative days 0-7
This will be the average daily opioid use in the hospital
Time frame: Postoperative days 0-7
Duration of hospital stay in days
Time frame: Preoperative baseline, postoperative days 1-2
This is a validated 15-question assessment of quality of recovery
Time frame: Postoperative days 0-3
Anxiety and depression assessment for the hospitalization
Time frame: Day of surgery (postoperative day 0), postoperative days 30, 90, 180 and 365
Patient-reported daily opioid use on average in mg
Time frame: Day of surgery (postoperative day 0), postoperative days 30, 90, 180, and 365
This is the prescribed daily opioids confirmed from the PDMP.
Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Nausea and vomiting measured on the following scale: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective
Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Constipation: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective
Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
Puritus: 0=AE not experienced; 1=AE experienced but no treatment needed; 2=AE experienced and treatment was effective; 3=AE experienced and treatment was ineffective
Time frame: Postoperative days 0, 1, 2, 3, 30, 90, 180, and 365
0-10 scale with 0 being worst possible pain control and 10 being best possible pain control
Time frame: Baseline, day of surgery (postoperative day 0), and postoperative days 30, 90, 180, and 365
This is a brief assessment of physical and mental function
Contact information is provided by the study sponsor or research team.
Eric Schwenk, MD
CONTACT
Jeffrey Mojica, DO
CONTACT
Thomas Jefferson University
Other
A Pilot Study of the Feasibility of Preoperative Opioid Tapering Before Spine Surgery Using Cognitive Behavioral Therapy and Measuring Postoperative Outcomes
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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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