NCT05327777

Toward Zero Prescribed Opioids for Outpatient General Surgery

Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: a Prospective Cohort Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

Investigators have created an opioid reduction "package" which includes patient education, non-narcotic pain control instructions, and limited (or no) opioid pain prescriptions provided at discharge in an attempt to reduce the number of opioid consumption after outpatient general surgery.

Detailed description

Between November 2019 and July 2021, patients undergoing elective inguinal hernia repair (IHR) or cholecystectomy were enrolled in the study. Patients were divided into three cohorts: Control, opioid sparing (OS), or zero-opioid (ZO). Control patients did not have any intervention; OS patients had an opioid reduction intervention protocol applied (patient education and perioperative multimodal analgesia) and were provided an opioid prescription at discharge; the ZO had the same protocol, however patients were not provided opioid prescriptions at discharge. Two weeks after discharge patients were interviewed to record opioid consumption, pain scores, and level of satisfaction since discharge.

Conditions

• Opioid Misuse and Addiction
• Pain

Interventions

Type	Name	Description
DRUG	Oxycodone	Investigators provided set opioid prescriptions for 10 pills each patient.
BEHAVIORAL	Zero Opioid Protocol	Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-07-30
• Completion: 2023-03-15
• First posted: 2022-04-14
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study