Toward Zero Prescribed Opioids for Outpatient General Surgery

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Thomas Jefferson University

Status and phase

Completed
Phase 4

Conditions

Opioid Misuse and Addiction
Pain

Treatments

Drug: Oxycodone
Behavioral: Zero Opioid Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT05327777
19D.688

Details and patient eligibility

About

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.

Full 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.

Enrollment

129 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

129 participants in 3 patient groups

Control
No Intervention group
Description:
Normal standard practices
Opioid Sparing
Experimental group
Description:
Providers required to prescribe 10 narcotic pills only
Treatment:
Drug: Oxycodone
Zero Opioid
Experimental group
Description:
No narcotic prescription is provided to patient at discharge
Treatment:
Behavioral: Zero Opioid Protocol

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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