Pain Control Without Opioids

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hackensack Meridian Health
• Treatments: Ibuprofen; Oxycodone

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The subject will be withdrawn from the study prior to any randomization if the following occurs: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