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Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers

Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06167759
Enrollment
240
Registered
2023-12-12
Start date
2022-12-05
Completion date
2024-04-30
Last updated
2023-12-12

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

Conditions

Inguinal Hernia, Opioid Use, Ventral Hernia

Brief summary

The effect of pain agreements to reduce opioid misuse is an accepted practice in many settings, but it has never been applied to the acute care setting. Pain agreements are considered the standard of care for chronic pain management reliant on opioid prescribing, and they are a mandated component of care in many states. Therefore, the adjunct of safe opioid use agreements into acute pain management offers a logical extension of current practices from chronic pain management. This study will test the use of agreements to improve safe opioid use to prevent misuse and opioid-related harm.

Interventions

OTHEROpioid Use Agreement

This was previously developed specifically for surgical patients using a modified Delphi method with a group of experts (including surgeons, nurses, advanced practices providers, quality improvement experts, and patients).

Sponsors

Northwestern University
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients (at least 18 years of age), of any gender, who speak English or Spanish, undergoing general surgery procedures with a high likelihood of receiving an opioid prescription (bariatric, inguinal hernia, or ventral hernia), who have their preoperative appointment at UT Physicians Health Center at Memorial Hermann Sugar Land Medical Plaza, Lyndon Baines Johnson, and Bellaire

Exclusion criteria

Patients with a known allergy or contra-indication to opioids, pregnancy, signification cognitive impairment, history of opioid misuse/abuse, chronic opioid use, readmission before the follow up appointment

Design outcomes

Primary

MeasureTime frameDescription
Patient self-reported disposal of prescription opioids25-40 days after surgeryPatient self-reported disposal of prescription opioids

Secondary

MeasureTime frameDescription
Opioid pills leftover25-40 days after surgeryNumber of opioid pills left over if opioid prescription was filled
Opioid pills used25-40 days after surgeryNumber of opioid pill used if opioid prescription was filled
Storage method25-40 days after surgeryIf opioid prescription was filled, how the opioid pills were stored
Disposal method25-40 days after surgeryIf opioid prescription was filled, how the opioid pills were disposed
Other pain management strategies25-40 days after surgeryOther pain management strategies that were used

Countries

United States

Outcome results

None listed

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