Toward Zero Prescribed Opioids for Outpatient General Surgery

Phase 4

Completed

• Conditions: Opioid Misuse and Addiction; Pain
• Interventions: Drug: Oxycodone; Behavioral: Zero Opioid Protocol

• Registration Number: NCT05327777
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2021-07-30
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Results First Submitted: 2023-02-02
• Study Completion: 2023-03-15
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-02
• Last Update Submitted: 2023-06-02
• Results First Posted: 2023-06-05
• Last Update Posted: 2023-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Sparing	Oxycodone	Providers required to prescribe 10 narcotic pills only
Zero Opioid	Zero Opioid Protocol	No narcotic prescription is provided to patient at discharge

Primary Outcome Measures

Name	Time	Method
Morphine Milligram Equivalents Taken by Participants	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 Outcome Measures

Name	Time	Method
Satisfaction Scores Ranging From 1 - 10	14 days	Patient will be asked to rank their satisfaction scores on a scale from 1 - 10 (with 1 being extremely dissatisfied and 10 being extremely satisfied) since discharge from the hospital

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States