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Clinical Trials/NCT05327777
NCT05327777
Completed
Phase 4

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

Thomas Jefferson University1 site in 1 country129 target enrollmentNovember 1, 2019

Overview

Phase
Phase 4
Intervention
Oxycodone
Conditions
Opioid Misuse and Addiction
Sponsor
Thomas Jefferson University
Enrollment
129
Locations
1
Primary Endpoint
Morphine Milligram Equivalents Taken by Participants
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
March 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Opioid naïve patients
  • Age \> 18
  • Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy

Exclusion Criteria

  • Urgent/emergent status
  • Previous cholecystostomy tube placement

Arms & Interventions

Opioid Sparing

Providers required to prescribe 10 narcotic pills only

Intervention: Oxycodone

Zero Opioid

No narcotic prescription is provided to patient at discharge

Intervention: Zero Opioid Protocol

Outcomes

Primary Outcomes

Morphine Milligram Equivalents Taken by Participants

Time Frame: 14 days

Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals

Secondary Outcomes

  • Satisfaction Scores Ranging From 1 - 10(14 days)

Study Sites (1)

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