Opioid Counseling Following Orthopaedic Surgery
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ClinicalTrials.gov Identifier: NCT04138264 |
Recruitment Status :
Completed
First Posted : October 24, 2019
Last Update Posted : October 24, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Orthopedic Disorder | Other: Preoperative opioid counseling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 237 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling |
Actual Study Start Date : | June 19, 2018 |
Actual Primary Completion Date : | November 2, 2018 |
Actual Study Completion Date : | May 1, 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Peroperative counseling |
Other: Preoperative opioid counseling
preoperative counseling consists of education with a brief multi-media presentation in the preoperative area on the day of surgery using a handheld tablet. The message of the preoperative counseling consisted of: 1) Background on the opioid epidemic including basic facts and consequences, 2) Description of risk factors for opioid abuse and how to consume opioids safely, 3) Information on the specific opioid the patient was prescribed and the anticipated amount and duration of use postoperatively, 4) Encouraging the use of non-opioid therapy prior to taking the prescribed opioids or quickly transitioning to non-opioid medications postoperatively, and 5) Contact information and instructions to call if the patient experienced any adverse events and/or if additional pain medication is needed. |
No Intervention: No preoperative counseling |
- Number of pills consumed [ Time Frame: Up to 6 weeks ]Patients asked to keep daily diary which includes number of pills consumed during the post-operative period
- Morphine equivalents (MEQ) [ Time Frame: Up to 6 weeks ]MEQs is a standardized method of comparing different types of pain medication with a gold-standard. All pain medication can be converted to MEQs
- Visual Analog Scale (pain) Pain [ Time Frame: Up to 6 weeks ]Pain as reported by patients on a daily basis via diaries
- Patient satisfaction with pain management: 5 point Likert Scale [ Time Frame: Up to 6 weeks ]Satisfaction with pain management as reported daily by patients using a 5 point Likert Scale

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing shoulder, elbow, wrist, knee, foot, and/or ankle surgery
Exclusion Criteria:
- male of female less than 18 years old
- patients schedule to undergo inpatient procedures
- patients undergoing surgeries distal to the wrist
- patients undergoing surgeries under local anesthesia only

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04138264
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19148 |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT04138264 |
Other Study ID Numbers: |
Ilyas2019 |
First Posted: | October 24, 2019 Key Record Dates |
Last Update Posted: | October 24, 2019 |
Last Verified: | October 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Musculoskeletal Diseases Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |