Opioid Free Management After Ureteroscopy

Wake Forest University (WFU)

Status and phase: Completed; Phase 4

Conditions: Kidney Stone

Treatments: Drug: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED; Drug: Norco 5milligram-325milligram Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03872843

IRB00056720

Details and patient eligibility

About

The purpose of this research study is to compare how well two medications work to control post-operative pain.

Full description

This will be a randomized double blinded control trial with subjects randomized to either opioid group (Norco 5-325 milligram) or a non-opioid group (Ibuprofen 400 milligram). Subjects with a renal stones who are consented for a ureteroscopy will be eligible for the study. Subjects eligible for the study will have a discussion with the study team member about treatment options. Subjects can either elect not to be in the study and actively choose which treatment is preferable, or the subject can choose to enter the study and be randomized to one of these treatment arms. The ureteroscopy will be performed using standard of care instruments and techniques. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. Post operatively; investigators plan to discharge all subjects home from the recovery unit. All subjects will be seen one week after surgery for follow up, questioner filling and stent removal.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ureteroscopy performed for renal stones
• Age over 18 years
• Two kidneys

Exclusion criteria

• Solitary Kidney
• Poor kidney function (GFR<30)
• Allergy to either Ibuprofen or Norco
• Pelvic Kidney

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Opioid Group

Active Comparator group

Description:

This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Norco 5milligram-325milligram Tablet for postoperative pain after ureteroscopy with stent placement.

Treatment:

Drug: Norco 5milligram-325milligram Tablet

Non-Opioid Group

Active Comparator group

Description:

This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Ibuprofen 400 milligram for postoperative pain after ureteroscopy with stent placement.

Treatment:

Drug: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED