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

• ClinicalTrials.gov Identifier: NCT05965492
• Recruitment Status: Not yet recruiting
• First Posted: July 28, 2023
• Sponsor: University of Miami
• Information provided by (Responsible Party): Yiliam Rodriguez, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Disorder	Drug: Acetaminophen; Drug: Celebrex; Drug: Gabapentin; Drug: Famotidine; Drug: Decadron; Drug: Oxycodone	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: June 1, 2024
• Estimated Primary Completion Date: June 1, 2025
• Estimated Study Completion Date: June 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Adherence measured by the self-report medication nonadherence scale [ Time Frame: up to 7 days ]
   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.
2. Satisfaction measured by Satisfaction Likert Scale [ Time Frame: up to 7 days ]
   Scores range from "0" not satisfied to "10" very satisfied
3. Ease of use as measured by Likert Scale [ Time Frame: up to 7 days ]
   Scores ranges from "strongly disagree to Strongly agree" regarding the ease of use of the medication package.

Secondary Outcome Measures :

1. Number of pain pills [ Time Frame: up to 7 days ]
   Count of pills taken by participants

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Yiliam Rodriguez, MD; (305) 5855456; yrodriguez4@miami.edu

Locations

United States, Florida

University of Miami

Miami, Florida, United States, 33136

Contact: Maria Antor 305-587-7677 mantor@miami.edu

Principal Investigator: Yiliam Rodriguez, MD

Sponsors and Collaborators

University of Miami

Investigators

• Principal Investigator: Yiliam Yiliam, MD; Professor of Clinical

More Information

• Responsible Party: Yiliam Rodriguez, Professor of Clinical, University of Miami
• ClinicalTrials.gov Identifier: NCT05965492
• Other Study ID Numbers: 20230423
• First Posted: July 28, 2023
• Last Update Posted: May 3, 2024
• Last Verified: May 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Acetaminophen; Celecoxib; Oxycodone; Gabapentin; Famotidine; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Anti-Inflammatory Agents; Gastrointestinal Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Anticonvulsants; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Antimanic Agents; Anti-Inflammatory Agents, Non-Steroidal