Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
Study Details
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 |
|---|---|---|
| Phase 3 |
Study Design
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
- Adherence measured by the self-report medication nonadherence scale [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.
- Satisfaction measured by Satisfaction Likert Scale [up to 7 days]
Scores range from "0" not satisfied to "10" very satisfied
- Ease of use as measured by Likert Scale [up to 7 days]
Scores ranges from "strongly disagree to Strongly agree" regarding the ease of use of the medication package.
Secondary Outcome Measures
- Number of pain pills [up to 7 days]
Count of pills taken by participants
Eligibility Criteria
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)
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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
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Inability to be discharged home on the day of surgery
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Inability to swallow pills
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
Investigators
- Principal Investigator: Yiliam Yiliam, MD, Professor of Clinical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20230423