Spinal Disorder
Conditions
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.
Interventions
DRUGAcetaminophen
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.
DRUGCelebrex
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.
DRUGGabapentin
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.
DRUGFamotidine
Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.
DRUGDecadron
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.
DRUGOxycodone
A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of pain pills | up to 7 days | Count of pills taken by participants |
Outcome results
None listed