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

University of Miami

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Spinal Disorder

Interventions

AcetaminophenDRUG

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.

CelebrexDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: up to 7 days

Satisfaction measured by Satisfaction Likert Scale

Scores range from "0" not satisfied to "10" very satisfied

Time frame: up to 7 days

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.

Time frame: up to 7 days

Secondary Outcomes

Number of pain pills

Count of pills taken by participants

Time frame: up to 7 days

Data from ClinicalTrials.gov

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