Back to resultsMultimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
Primary Purpose
Spinal Disorder
Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Celebrex
Gabapentin
Famotidine
Decadron
Oxycodone
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Disorder
Eligibility 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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bottled pain formulations Group
Multi-Modal regimen Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Satisfaction measured by Satisfaction Likert Scale
Scores range from "0" not satisfied to "10" very satisfied
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.
Secondary Outcome Measures
Number of pain pills
Count of pills taken by participants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05965492
Brief Title
Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bottled pain formulations Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Multi-Modal regimen Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Celebrex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Famotidine
Intervention Description
Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.
Intervention Type
Drug
Intervention Name(s)
Decadron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.
Primary Outcome Measure Information:
Title
Adherence measured by the self-report medication nonadherence scale
Description
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.
Time Frame
up to 7 days
Title
Satisfaction measured by Satisfaction Likert Scale
Description
Scores range from "0" not satisfied to "10" very satisfied
Time Frame
up to 7 days
Title
Ease of use as measured by Likert Scale
Description
Scores ranges from "strongly disagree to Strongly agree" regarding the ease of use of the medication package.
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
Number of pain pills
Description
Count of pills taken by participants
Time Frame
up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiliam Rodriguez, MD
Phone
(305) 5855456
Email
yrodriguez4@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiliam Yiliam, MD
Organizational Affiliation
Professor of Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Antor
Phone
305-587-7677
Email
mantor@miami.edu
First Name & Middle Initial & Last Name & Degree
Yiliam Rodriguez, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
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