Status:
WITHDRAWN
Pain Control Without Opioids
Lead Sponsor:
Hackensack Meridian Health
Conditions:
Perioperative Pain
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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-opi...
Detailed Description
Death from opioid overdose is now considered a national emergency. Prescribing of narcotics by physicians, particularly in the perioperative period, remains a significant contributor to opioid addicti...
Eligibility Criteria
Inclusion
- Ages 18-90
- English or Spanish speaking
- Undergoing routine laparoscopic appendectomy or cholecystectomy
- Able to provide Informed Consent
Exclusion
- 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- The subject will be withdrawn from the study prior to any randomization if the following occurs: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.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04813991
Start Date
March 15 2022
End Date
September 1 2025
Last Update
September 10 2022
Active Locations (1)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601