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

University of Miami

Status and phase: Withdrawn; Phase 3

Conditions: Spinal Disorder

Treatments: Drug: Gabapentin; Drug: Acetaminophen; Drug: Decadron; Drug: Famotidine; Drug: Celebrex; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT05965492

20230423

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Bottled pain formulations Group

Active Comparator group

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.

Treatment:

Drug: Oxycodone

Drug: Famotidine

Drug: Celebrex

Drug: Decadron

Drug: Acetaminophen

Drug: Gabapentin

Multi-Modal regimen Group

Experimental group

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.

Treatment:

Drug: Oxycodone

Drug: Famotidine

Drug: Celebrex

Drug: Decadron

Drug: Acetaminophen

Drug: Gabapentin