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Pain Control Without Opioids

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04813991
Recruitment Status : Not yet recruiting
First Posted : March 24, 2021
Last Update Posted : November 10, 2021
Sponsor:
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief Summary:
Adequate outpatient pain control after uncomplicated laparoscopic appendectomy or cholecystectomy can be achieved with minimal breakthrough drugs when used in combination with around the clock non-opioid medications.

Condition or disease Intervention/treatment Phase
Perioperative Pain Drug: Ibuprofen 600 mg Drug: OxyCODONE 5 Mg Oral Capsule Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Double-Blind Intervention Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple Blinded
Primary Purpose: Treatment
Official Title: Achieving Peri-Operative Pain Control Without Opioids
Estimated Study Start Date : January 15, 2022
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1 - Ibuprofen Breakthrough
600 mg Ibuprofen for breakthrough pain.
Drug: Ibuprofen 600 mg
Ibuprofen 600 mg for breakthrough pain.

Active Comparator: Arm 2 - Oxycodone Breakthrough
5 mg of Oxycodone for breakthrough pain.
Drug: OxyCODONE 5 Mg Oral Capsule
OxyCODONE 5 Mg Oral Capsule for breakthrough pain.




Primary Outcome Measures :
  1. Incidence of Breakthrough Pain [ Time Frame: 7 Days ]
    The need for breakthrough pain medication will be characterized by the estimate of the incidence density for starting breakthrough medication. We will examine potential predictors of the need for breakthrough medication using an actuarial approach


Secondary Outcome Measures :
  1. Time-weighted average daily pain score over first three days post-discharge. [ Time Frame: 3 Days ]
    The subjects will maintain a pain log and will record their pain intensity prior to meals each day, and also the maximum pain intensity for the given day, using a verbal pain Numerical Rating Scale (NRS) that ranges from 0 to 10. We will use a general linear model (GLM) approach comparing time-weighted average pain scores over 72-hours as the dependent variable.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18-90
  • English or Spanish speaking
  • Undergoing routine laparoscopic appendectomy or cholecystectomy
  • Able to provide Informed Consent

Exclusion Criteria:

  • Current use of methadone
  • Opioid use within 30 days prior to hospitalization
  • Actively taking anti-inflammatory medications
  • History of Adverse Reactions to Study Medications
  • Pregnancy
  • Currently Breastfeeding
  • Ongoing treatment for Peptic Ulcer Disease
  • Hepatitis, cirrhosis, severe liver dysfunction (elevated MELD score or LFT's > twice the upper limit of normal.)
  • Renal dysfunction with a creatinine more than 25% above age normal values.
  • Taking any medicine that might interact with one of the study medications such as SSRI's or Tricyclics, anti-psychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort

The subject will be withdrawn from the study prior to any randomization if the following occurs:

  • Conversion from laparoscopic to open procedure
  • Subject does not undergo any operation;
  • Subject has a complicated hospital course requiring prolonged hospitalization; subject experiences post-operative complications.

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): NCT04813991


Locations
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United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Contact: Melissa Blatt, MSN    551-996-2609    melissa.blatt@hmhn.org   
Contact: Tania Zielonka, CCRP    551-996-2000 ext 4452    tania.zielonka@hmhn.org   
Principal Investigator: Samuel Hawkins, MD         
Sponsors and Collaborators
Hackensack Meridian Health
Publications:
Michigan OPEN. Opioid Prescribing Recommendations for Opioid-Naive Patients. https://opioidprescribing.info. Published 2018. Accessed September 17, 2019.

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT04813991    
Other Study ID Numbers: PRO2020-0546
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: November 10, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Keywords provided by Hackensack Meridian Health:
Opioid Analgesic
Ibuprofen
Pain control
Acetaminophen
Laparoscopic Cholescystectomy
Laparoscopic Appendectomy
Additional relevant MeSH terms:
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Ibuprofen
Oxycodone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants