Using Honest Placebos to Improve Pain Management in Hand Surgery Patients

Early Phase 1

Completed

• Conditions: Hand or Wrist Surgery
• Interventions: Drug: Open Placebo

• Registration Number: NCT03631251
• Lead Sponsor: Brown University

Brief Summary

America is in the midst of an opioid epidemic. One of the reasons opioid addiction and overdose deaths have recently increased is that doctors are frequently prescribing opioid medication as a treatment for pain. If it is possible to develop new ways of increasing the pain-relief patients experience from a set amount of opioids, then doctors might ultimately be able to prescribe fewer opioid medications, which could help curb the opioid crisis.

Although "placebos," a medication whose benefit derives solely from positive psychological factors rather than pharmacological factors, are often disparaged in medicine, research suggests that placebos can actually help reduce pain. In fact, there is reason to think that placebos are effective even when a patient knows they are taking a placebo.

The goal of the proposed study is to examine the feasibility of using an honest placebo to relieve pain for up to 20 real patients. People who are undergoing hand or wrist surgery or enrolled for upper extremity trauma in the Emergency Department and agree to participate will be asked to take placebo pills in addition to their standard course of opioid pills, given as part of standard care. Patients will also answer a few short questions over the phone once per day for seven days, and be invited to participate in an exit questionnaire at the end of the study. The investigators hypothesize that: 1) At least 50% of eligible participants will agree to enroll, 2) At least 80% of participants who are enrolled will be retained, and 3) Participants who are enrolled will take a placebo at least 50% of the time they also take an opioid pill

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2018-08-17
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Placebo	Open Placebo	Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.

Primary Outcome Measures

Name	Time	Method
Enrollment Percentage	Through study enrollment, 1 day	Percentage of Eligible Patients who Enroll
Retention Rate	through study completion, approximately 2 months	Percentage of Patients who are Retained at follow-up
Placebo Intake	7 days	Number of Placebos Participants Take
Placebo Analgesia	7 days	Analgesia associated with placebo pills

Trial Locations

Locations (2)

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

University Orthopedics; 🇺🇸 East Providence, Rhode Island, United States