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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05327777
Other study ID # 19D.688
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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