Toward Zero Prescribed Opioids for Outpatient General Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327777
• Other study ID #: 19D.688
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: March 15, 2023

Study information

• Verified date: June 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 15, 2023
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine Milligram Equivalents Taken by Participants	Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals	14 days
Secondary	Satisfaction Scores Ranging From 1 - 10	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	14 days