Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Toward Zero Prescribed Opioids for Outpatient General Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05327777
Recruitment Status : Active, not recruiting
First Posted : April 14, 2022
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Opioid Misuse and Addiction Pain Drug: Oxycodone Behavioral: Zero Opioid Protocol Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control group, opioid sparing arm, and zero opioid arm
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Toward Zero Prescribed Opioids for Outpatient General Surgery Procedures: a Prospective Cohort Trial
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : July 30, 2021
Estimated Study Completion Date : May 15, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxycodone

Arm Intervention/treatment
No Intervention: Control
Normal standard practices
Experimental: Opioid Sparing
Providers required to prescribe 10 narcotic pills only
Drug: Oxycodone
Investigators provided set opioid prescriptions for 10 pills each patient.

Experimental: Zero Opioid
No narcotic prescription is provided to patient at discharge
Behavioral: Zero Opioid Protocol
Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.




Primary Outcome Measures :
  1. Number of opioid pills reported being taken by the patient. [ 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 Outcome Measures :
  1. Pain Scale Scores Ranging from 1 - 10 [ Time Frame: 14 days ]
    Patient will be asked to rank their average pain scores on a scale from 1 - 10 (with 1 being no pain and 10 being the worst pain they have ever felt in their life) since discharge from the hospital

  2. Satisfaction Scores Ranging from 1 - 10 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05327777


Locations
Layout table for location information
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Layout table for investigator information
Study Director: Walter Kraft, MD Thomas Jefferson University
Layout table for additonal information
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT05327777    
Other Study ID Numbers: 19D.688
First Posted: April 14, 2022    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plans to share the IPD

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents