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
Overview
- Phase
- Phase 3
- Intervention
- Acetaminophen
- Conditions
- Spinal Disorder
- Sponsor
- University of Miami
- Enrollment
- 100
- Primary Endpoint
- Satisfaction measured by Satisfaction Likert Scale
- Status
- Withdrawn
- Last Updated
- 11 months ago
Overview
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.
Investigators
Yiliam Rodriguez
Professor of Clinical
University of Miami
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
Arms & Interventions
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.
Intervention: Acetaminophen
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.
Intervention: Celebrex
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.
Intervention: Gabapentin
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.
Intervention: Famotidine
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.
Intervention: Decadron
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.
Intervention: Oxycodone
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.
Intervention: Acetaminophen
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.
Intervention: Celebrex
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.
Intervention: Gabapentin
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.
Intervention: Famotidine
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.
Intervention: Decadron
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.
Intervention: Oxycodone
Outcomes
Primary Outcomes
Satisfaction measured by Satisfaction Likert Scale
Time Frame: up to 7 days
Scores range from "0" not satisfied to "10" very satisfied
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.
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 Outcomes
- Number of pain pills(up to 7 days)