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

NCT05965492 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 20230423
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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

• Satisfaction measured by Satisfaction Likert Scale

  Scores range from "0" not satisfied to "10" very satisfied

  up to 7 days

• 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 Outcomes (1)

• Number of pain pills

  up to 7 days

Study Arms (2)

Bottled pain formulations Group

ACTIVE COMPARATOR

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.

Drug: Acetaminophen; Drug: Celebrex; Drug: Gabapentin; Drug: Famotidine; Drug: Decadron; Drug: Oxycodone

Multi-Modal regimen Group

EXPERIMENTAL

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.

Drug: Acetaminophen; Drug: Celebrex; Drug: Gabapentin; Drug: Famotidine; Drug: Decadron; Drug: Oxycodone

Interventions

Acetaminophen DRUG

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.

Bottled pain formulations Group; Multi-Modal regimen Group

Celebrex DRUG

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.

Bottled pain formulations Group; Multi-Modal regimen Group

Gabapentin DRUG

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.

Bottled pain formulations Group; Multi-Modal regimen Group

Famotidine DRUG

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

Bottled pain formulations Group; Multi-Modal regimen Group

Decadron DRUG

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.

Bottled pain formulations Group; Multi-Modal regimen Group

Oxycodone DRUG

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

Bottled pain formulations Group; Multi-Modal regimen Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Spinal Diseases

Interventions

Acetaminophen; Celecoxib; Gabapentin; Famotidine; Calcium Dobesilate; Oxycodone

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Thiazoles; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Yiliam Yiliam, MD

  Professor of Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 28, 2023
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share