Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery

Spinal Disorder Clinical Trial

Official title:

Optimal Multimodal Pain Management Package Versus Regular Bottled Pain Formulation for Outpatient Use Following Microdiscectomies , Foraminotomies, and Spinal Decompressions: A Randomized Control Trial Comparing Two Strategies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05965492
• Other study ID #: 20230423
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2024
• Source: University of Miami
• Contact: Yiliam Rodriguez, MD
• Phone: (305) 5855456
• Email: yrodriguez4[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Diseases
• Spinal Disorder

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	university of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence measured by the self-report medication nonadherence scale	Adherence will be measured using a Likert scale ranging from "never" indicating that the participant followed all instructions and adhered to the medication to "all the time. "indicating that the participant never followed instructions and did not take the medication.	up to 7 days
Primary	Satisfaction measured by Satisfaction Likert Scale	Scores range from "0" not satisfied to "10" very satisfied	up to 7 days
Primary	Ease of use as measured by Likert Scale	Scores ranges from "strongly disagree to Strongly agree" regarding the ease of use of the medication package.	up to 7 days
Secondary	Number of pain pills	Count of pills taken by participants	up to 7 days