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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Disorder
• Intervention / Treatment: Drug: Acetaminophen; Drug: Celebrex; Drug: Gabapentin; Drug: Famotidine; Drug: Decadron; Drug: Oxycodone

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Yiliam Rodriguez, MD; Phone Number: 305-585-7677; Email: yrodriguez4@med.miami.edu
      • Contact: Maria A Antor, MSPH; Phone Number: 3055857677; Email: mantor@med.miami.edu
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • University of Miami
      • Contact: Maria Antor; Phone Number: 305-587-7677; Email: mantor@miami.edu
      • Principal Investigator: Yiliam Rodriguez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Drug: 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.; Drug: 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.; Drug: Famotidine; Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.; Drug: 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.; Drug: Oxycodone; A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.
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.	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.; Drug: 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.; Drug: 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.; Drug: Famotidine; Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.; Drug: 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.; Drug: Oxycodone; A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pain pills	Count of pills taken by participants	up to 7 days

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Yiliam Yiliam, MD, Professor of Clinical

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Enzyme Inhibitors; Antirheumatic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Analgesics, Opioid; Narcotics; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anticonvulsants; Antimanic Agents; Excitatory Amino Acid Agents; Excitatory Amino Acid Antagonists; Anti-Ulcer Agents; Cyclooxygenase 2 Inhibitors; Histamine H2 Antagonists; Gabapentin; Celecoxib; Acetaminophen; Oxycodone; Famotidine
• Other Study ID Numbers: 20230423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No