Spinal DisorderPhase 3NCT05965492
Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery
A Phase 3 study testing Acetaminophen, Celebrex and Gabapentin in people with Spinal Disorder, run by University of Miami.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Disorder
- What is being tested?
- Acetaminophen, Celebrex and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults: males or non-pregnant females.
- Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics.
Who cannot join
- 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
Show all 20Show fewer
- 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.
About this study
Official title: 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
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.
- Conditions
- Spinal Disorder
- Being tested
- Acetaminophen, Celebrex, Gabapentin, Famotidine, Decadron
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
GabapentinDrug
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.
FamotidineDrug
Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.
DecadronDrug
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.
OxycodoneDrug
A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.
| Study group | Role | What they receive |
|---|---|---|
| Bottled pain formulations Group | Active comparator | 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. Receives: Drug: Acetaminophen; Drug: Celebrex; Drug: Gabapentin; Drug: Famotidine; Drug: Decadron; Drug: Oxycodone |
| Multi-Modal regimen Group | Experimental | 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. Receives: Drug: Acetaminophen; Drug: Celebrex; Drug: Gabapentin; Drug: Famotidine; Drug: Decadron; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days
Satisfaction measured by Satisfaction Likert Scale
Scores range from "0" not satisfied to "10" very satisfied
Measured: 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.
Measured: up to 7 days
Secondary outcomes (1)
Number of pain pills
Count of pills taken by participants
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jun 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: Study drug was not compliant with research pharmacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DisorderStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiliam Rodriguez, University of Miami
- Investigators
- Yiliam Yiliam, MD, Principal investigator, Professor of Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965492
- Sponsor's protocol ID
- 20230423
- Status last verified
- May 2025
- First submitted
- 12 Jul 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05965492
- Acronym / sponsor ID
- 20230423
- Conditions
- Spinal Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study drug was not compliant with research pharmacy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bottled pain formulations Group | Active comparator | Drug: Acetaminophen, Drug: Celebrex, Drug: Gabapentin, Drug: Famotidine, Drug: Decadron, Drug: OxycodoneParticipants 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 | Experimental | Drug: Acetaminophen, Drug: Celebrex, Drug: Gabapentin, Drug: Famotidine, Drug: Decadron, Drug: OxycodoneParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults: males or non-pregnant females.
- Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics.
Key exclusion criteria (20 listed)
- Pregnancy
- Active severe liver disease
- Chronic kidney disease 3a-5 (moderate to severe)
- Chronic obstructive pulmonary disease with impaired pulmonary function
- Chronic steroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenDay 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. | Drug | Bottled pain formulations Group, Multi-Modal regimen Group |
| CelebrexDay 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. | Drug | Bottled pain formulations Group, Multi-Modal regimen Group |
| GabapentinDay 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. | Drug | Bottled pain formulations Group, Multi-Modal regimen Group |
| FamotidineDay 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg. | Drug | Bottled pain formulations Group, Multi-Modal regimen Group |
| DecadronDay 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. | Drug | Bottled pain formulations Group, Multi-Modal regimen Group |
| OxycodoneA prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain. | Drug | Bottled pain formulations Group, Multi-Modal regimen Group |
Primary outcome
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.
Satisfaction measured by Satisfaction Likert Scale
Time frame: up to 7 days
Scores range from "0" not satisfied to "10" very satisfied
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.
1 secondary outcome
Number of pain pills
Time frame: up to 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yiliam Yiliam, MD principal investigator
Professor of Clinical
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetaminophen, Celebrex and Gabapentin in people with Spinal Disorder, run by University of Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence measured by the self-report medication nonadherence scale (time frame: up to 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.