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Opioid Counseling Following Orthopaedic Surgery

Opioid Consumption After Orthopaedic Surgery: Prospective Randomized Trial on the Effects of Pre-Operative Counseling

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04138264
Enrollment
237
Registered
2019-10-24
Start date
2018-06-19
Completion date
2019-05-01
Last updated
2019-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Disorder

Brief summary

Postoperative pain management and opioid consumption following outpatient orthopaedic surgery may be influenced by a number of variables including knowledge of safe opioid use. A prospective randomized study is designed to understand the effect of preoperative opioid counseling on postoperative opioid consumption and the typical opioid consumption patterns following common outpatient orthopaedic surgeries. The hypothesis was that patients who received preoperative opioid counseling will consume less postoperative opioid medication and experience greater satisfaction with pain management.

Interventions

OTHERPreoperative 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.

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of pills consumedUp to 6 weeksPatients asked to keep daily diary which includes number of pills consumed during the post-operative period

Secondary

MeasureTime frameDescription
Morphine equivalents (MEQ)Up to 6 weeksMEQs 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) PainUp to 6 weeksPain as reported by patients on a daily basis via diaries
Patient satisfaction with pain management: 5 point Likert ScaleUp to 6 weeksSatisfaction with pain management as reported daily by patients using a 5 point Likert Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026