Recruiting
Phase 3

Multimodal Pain Package vs. Regular Formulation

Sponsor:

University of Miami

Code:

NCT05965492

Conditions

Spinal Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

Celebrex

Gabapentin

Famotidine

Decadron

Study Details

Brief summary:

The purpose of this research is to compare two outpatient pain management strategies in patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal decompressions.

Conditions

Spinal Disorder

Study ID

NCT05965492

Start date

Jun 1, 2024

Status verified date

Jun, 2024

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults: males or non-pregnant females.
  • Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics.

Exclusion Criteria:

  • Pregnancy
  • Active severe liver disease
  • Chronic kidney disease 3a-5 (moderate to severe)
  • Chronic obstructive pulmonary disease with impaired pulmonary function
  • Chronic steroid use
  • Chronic opioid use
  • Current use of narcotics
  • Allergy to sulfonamides
  • Allergy to NSAIDs
  • Allergy to Aspirin
  • Allergy to Tylenol
  • Allergy to Gabapentins
  • Allergy to H2 blockers (cimetidine, famotidine)
  • Allergy to steroid
  • Current use of gabapentins for any medical condition
  • Inability to be discharged home on the day of surgery
  • Inability to swallow pills
  • Myasthenia gravis
  • History of gastrointestinal ulcers or stomach bleeding
  • Have any condition that, in the investigator's opinion, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Bottled pain formulations Group

Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.

experimental: Multi-Modal regimen Group

Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.

Interventions

Acetaminophen

Day 1 and Day 2: 1000 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 3000 mg.

Day 3 and Day 4: 825 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 2475 mg.

Day 5: 500 mg two times a day and 325 mg once a day administered via tablet by mouth for a total cumulative daily dose of 1325 mg.

Day 6: 500 mg once a day and 325mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1150 mg.

Day 7: 500 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1000 mg.

Celebrex

Day 1: 200 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 400 mg.

Day 2 and Day 3: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.

Day 4: 100 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.

Day 5: 50 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.

Not prescribed on Days 6 and 7.

Gabapentin

Day 1 and Day 2: 300 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 900 mg.

Day 3: 200 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 600 mg.

Day 4: 200 mg two times a day and 100mg once a day administered via tablet by mouth for a total cumulative daily dose of 500 mg.

Day 5: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.

Day 6: 100 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.

Day 7: 100 mg once a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.

Famotidine

Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.

Decadron

Day 1: 4 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 12 mg.

Day 2: 4 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 8 mg.

Day 3: 2 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 4 mg.

Not prescribed on Days 4 through 7.

Oxycodone

A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.

Primary outcome measure

  • Adherence measured by the self-report medication nonadherence scale [ Time Frame: up to 7 days ]
  • Satisfaction measured by Satisfaction Likert Scale [ Time Frame: up to 7 days ]
  • Ease of use as measured by Likert Scale [ Time Frame: up to 7 days ]

Central Contacts and Locations

Central contacts

Yiliam Rodriguez, MD

(305) 5855456yrodriguez4@miami.edu

Locations

university of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Yiliam Rodriguez, MD

305-585-7677yrodriguez4@med.miami.edu

Maria A Antor, MSPH

3055857677mantor@med.miami.edu

More Information

Sponsor

University of Miami

Last update posted

Jun 21, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2024-06-21.