Conditioned Open-label Placebo (COLP) for Peri-operative Pain Management in Patients With Head and Neck Cancer
- Conditions
- Postoperative PainOpioid Use
- Registration Number
- NCT04973748
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria:<br><br> - Patients receiving pre-operative evaluation for head and neck cancer in the<br> Otolaryngology - Head and Neck Surgery Department at Johns Hopkins Hospital<br><br> - Scheduled for surgery for resection of and/or reconstruction following resection of<br> a head and neck tumor between November 15, 2022 - May 15, 2024, with expected<br> inpatient admission of at least 5 days after surgery.<br><br> - Age 18 years or older<br><br> - Ability to comprehend and willingness to participate in open-label conditioning<br> portion of study regardless of study group assignment<br><br> - Ability to participate in study for 1 week prior to surgery and 6 months following<br> surgery at time of enrollment<br><br>Exclusion Criteria:<br><br> - Past medical history of substance use disorder<br><br> - Chronic pain (defined as pain lasting >3 months) or chronic opioid use (for >3<br> months).<br><br> - Contraindication to receiving acetaminophen, ibuprofen, oxycodone, or hydromorphone<br><br> - New gabapentin prescription started <2 weeks prior to surgery<br><br> - Psychosis, delirium or other significant cognitive impairment preventing<br> participation in study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in baseline daily morphine milligram equivalents (MME/day)
- Secondary Outcome Measures
Name Time Method Change in Pain assessed by Visual Analogue Scale;Change in Pain as assessed by the Functional Pain Scale;Change in Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9);Change in Numerical Opioid Side Effects (NOSE);Persistent opioid consumption at 6 months after surgery