Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
Phase 3
Recruiting
- Conditions
- Spinal Disorder
- Interventions
- Registration Number
- NCT05965492
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bottled pain formulations Group Oxycodone 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. Bottled pain formulations Group Acetaminophen 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. Bottled pain formulations Group Celebrex 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. Bottled pain formulations Group Gabapentin 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. Bottled pain formulations Group Famotidine 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. Bottled pain formulations Group Decadron 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. Multi-Modal regimen Group Celebrex 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. Multi-Modal regimen Group Acetaminophen 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. Multi-Modal regimen Group Gabapentin 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. Multi-Modal regimen Group Famotidine 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. Multi-Modal regimen Group Decadron 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. Multi-Modal regimen Group Oxycodone 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.
- Primary Outcome Measures
Name Time Method Satisfaction measured by Satisfaction Likert Scale up to 7 days Scores range from "0" not satisfied to "10" very satisfied
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.
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
Name Time Method Number of pain pills up to 7 days Count of pills taken by participants
Trial Locations
- Locations (2)
university of Miami
🇺🇸Miami, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States