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Placebo Therapy for Postoperative Pain

N/A

Recruiting

Led By Carole Fakhry, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Head and neck cancer patients undergoing cancer surgery and microvascular reconstruction.

Age 18 years or older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up daily after surgery up to 2 weeks, then weekly daily after surgery up to 1 month, then monthly daily after surgery up to 3 months, then once daily after surgery up to 6 months

Awards & highlights

Study Summary

This trialwill study whether using a placebo & odor to reduce opioid consumption in HNC patients is feasible & effective.

Who is the study for?

This trial is for adults over 18 with head and neck cancer who are about to have surgery and reconstruction. They must understand and agree to the study, which includes a placebo treatment. People with substance use disorders, chronic opioid use before their cancer diagnosis, or those who can't take common pain relievers or opioids due to health reasons cannot join.Check my eligibility

What is being tested?

The study tests if a conditioned open-label placebo (COLP), paired with an odor, can reduce opioid use after surgery compared to usual pain management alone. This method relies on patients associating the smell with relief without actual medication involved.See study design

What are the potential side effects?

Since COLP involves an inactive medication, it may not have direct side effects; however, potential risks include less effective pain control compared to standard treatments that could lead to increased discomfort post-surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having surgery for head or neck cancer with detailed tissue repair.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ daily after surgery up to 2 weeks, then weekly daily after surgery up to 1 month, then monthly daily after surgery up to 3 months, then once daily after surgery up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~daily after surgery up to 2 weeks, then weekly daily after surgery up to 1 month, then monthly daily after surgery up to 3 months, then once daily after surgery up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and daily after surgery up to 2 weeks, then weekly daily after surgery up to 1 month, then monthly daily after surgery up to 3 months, then once daily after surgery up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in baseline daily morphine milligram equivalents (MME/day)

Secondary outcome measures

Change in Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

Change in Numerical Opioid Side Effects (NOSE)

Change in Pain as assessed by the Functional Pain Scale

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Conditioned open-label placebo (COLP)Experimental Treatment2 Interventions

Standard pain regimen with scheduled acetaminophen and ibuprofen, oxycodone as needed for moderate-to-severe pain, and intravenous hydromorphone as needed for breakthrough pain. Conditioning (i.e. exposure to clove oil scent) with each dose of oxycodone medication on post-operative day (POD) 1-5. Scheduled placebo oxycodone medication paired with conditioning (i.e. exposure to clove oil scent) 3 times per day on POD 2-5. Surveys about pain levels, opioid consumption, side effects of opioids, understanding of placebo effect and symptoms of depression.

Group II: Treatment as usual (TAU)Active Control1 Intervention

Standard pain regimen with scheduled acetaminophen and ibuprofen, oxycodone as needed for moderate-to-severe pain, and intravenous hydromorphone as needed for breakthrough pain. Surveys about pain levels, opioid consumption, side effects of opioids, understanding of placebo effect and symptoms of depression.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Academy of Otolaryngology-Head and Neck Surgery FoundationOTHER

9 Previous Clinical Trials

1,334 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,263 Previous Clinical Trials

14,823,103 Total Patients Enrolled

4 Trials studying Postoperative Pain

115 Patients Enrolled for Postoperative Pain

University of MarylandOTHER

160 Previous Clinical Trials

302,221 Total Patients Enrolled

Media Library

Treatment as usual (TAU) Clinical Trial Eligibility Overview. Trial Name: NCT04973748 — N/A

Postoperative Pain Research Study Groups: Conditioned open-label placebo (COLP), Treatment as usual (TAU)

Postoperative Pain Clinical Trial 2023: Treatment as usual (TAU) Highlights & Side Effects. Trial Name: NCT04973748 — N/A

Treatment as usual (TAU) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04973748 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there remaining vacancies for participants in this clinical trial?

"The research project is presently enrolling participants, as indicated on clinicaltrials.gov; it was initially advertised on the 8th of February 2023 and has been recently revised to reflect current conditions also on that date."

Answered by AI

How many participants are actively participating in this research project?

"Affirmative. According to information on clinicaltrials.gov, this medical trial is still recruiting participants as of February 8th 2023. 30 individuals are needed at 1 medical location and the data was last updated in February 8th 2023."

Answered by AI

Recent research and studies

Journal of the American College of SurgeonsJournal

Guideline for Discharge Opioid Prescriptions After Inpatient General Surgical Procedures

Hill, Maureen V., Ryland S. Stucke, Sarah E. Billmeier, Julia L. Kelly, and Richard J. Barth. 2018. “Guideline for Discharge Opioid Prescriptions After Inpatient General Surgical Procedures”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jamcollsurg.2017.10.012.

Annals of SurgeryJournal

Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures

Hill, Maureen V., Michelle L. McMahon, Ryland S. Stucke, and Richard J. Barth. 2017. “Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0000000000001993.

Journal of General Internal MedicineJournal

The PHQ-9

Kroenke, Kurt, Robert L. Spitzer, and Janet B. W. Williams. 2001. “The PHQ-9”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1046/j.1525-1497.2001.016009606.x.

clinicaltrials.govStudy