Postoperative PainPhase 4NCT07203079
Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery
A Phase 4 study testing Acetaminophen Oral Tablet and Acetaminophen infusion in people with Postoperative Pain, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to compare whether oral or intravenous acetaminophen works better for pain control in patients undergoing lumbar spine fusion surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Acetaminophen Oral Tablet and Acetaminophen infusion
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Plan for open lumbar laminectomy and fusion surgery (1-3 levels)
- Able to provide written informed consent
- Must be able to swallow pills
Who cannot join
- Medical contraindications to acetaminophen
- Emergency surgery
- Chronic pain unrelated to surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Comparing 48-Hour Post-Operative Administration of Oral Versus Intravenous Acetaminophen in Patients Undergoing Lumbar Spine Fusion Surgery
The goal of this study is to compare whether oral or intravenous acetaminophen works better for pain control in patients undergoing lumbar spine fusion surgery
- Conditions
- Postoperative Pain
- Being tested
- Acetaminophen Oral Tablet, placebo oral tablet, Acetaminophen infusion, Placebo infusion
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen Oral TabletDrug
Also called Tylenol
Participants take 1000mg by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
placebo oral tabletDrug
Participants take one placebo tablet (matchable to tylenol) by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
Acetaminophen infusionDrug
Participants take 1000mg by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
Placebo infusionDrug
Participants take 1000mg placebo by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
| Study group | Role | What they receive |
|---|---|---|
| Oral Acetaminophen 1000mg | Active comparator | Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery Receives: Drug: Acetaminophen Oral Tablet; Drug: Placebo infusion |
| Intravenous Acetaminophen 1000mg | Experimental | Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery Receives: Drug: placebo oral tablet; Drug: Acetaminophen infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) Pain Intensity Scale Score
Mean pain intensity scores post-operatively using 11-point Numerical Rating Scale (NRS) (scale ranges from 0 to 10, and higher score means higher pain)
Measured: postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours
Secondary outcomes (10)
Length of Hospital Stay
Measured: After surgery until discharge, up to 10 days
Time to first ambulation after surgery
Measured: After surgery until discharge, up to 10 days
Quality of Life (EuroQol Questionaire) scale score
Participants rate their quality of life using the EuroQol-5D-5L questionnaire (scale from 1 to 5, 1 = no problem, 5 = severe problem)
Measured: 48 hours, up to 1 month after surgery
Cumulative opioid consumption
All opioid medications the patient takes after surgery will be converted to a morphine equivalent dose.
Measured: After surgery until discharge, up to 10 days
Healthcare cost during admission
Cost of hospital stay obtained from participant's Electronic Medical Record
Measured: After surgery until discharge, up to 10 days
Number of participants with treatment-related hepatic toxicity
Values above the normal range for any of these four lab tests (AST, ALT, INR, bilirubin) will be considered hepatic toxicity
Measured: postoperative time intervals: 2 hours(baseline), 24 hours, 48 hours
Number of participants with treatment-related skin rash
Per clinician assessment
Measured: After surgery until discharge, up to 10 days, whichever is first
Change in Patient Global Assessment Scale Score
Participants report their overall wellbeing as measured by 5-point Likert scale (ranging from 0-5, where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor)
Measured: postoperative time intervals: 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours
Time to first additional opioid medication dose
Additional opioid pain medication as requested by the participant which is not scheduled
Measured: After surgery until discharge, up to 10 days
Total number of additional opioid medication doses
Additional opioid pain medication as requested by the participant which is not scheduled
Measured: After surgery until discharge, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study startJan 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atman Desai, Stanford University
- Investigators
- Atman Desai, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203079
- Sponsor's protocol ID
- 82641
- Status last verified
- Oct 2025
- First submitted
- 24 Sep 2025
- Last updated
- 8 Oct 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 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial Comparing 48-Hour Post-Operative Administration of Oral Versus Intravenous Acetaminophen in Patients Undergoing Lumbar Spine Fusion Surgery
- ClinicalTrials.gov ID
- NCT07203079
- Acronym / sponsor ID
- 82641
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Oct 2025 (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 goal of this study is to compare whether oral or intravenous acetaminophen works better for pain control in patients undergoing lumbar spine fusion surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Acetaminophen 1000mg | Active comparator | Drug: Acetaminophen Oral Tablet, Drug: Placebo infusionParticipants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery |
| Intravenous Acetaminophen 1000mg | Experimental | Drug: placebo oral tablet, Drug: Acetaminophen infusionParticipants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Plan for open lumbar laminectomy and fusion surgery (1-3 levels)
- Able to provide written informed consent
- Must be able to swallow pills
Key exclusion criteria (4 listed)
- Medical contraindications to acetaminophen
- Emergency surgery
- Chronic pain unrelated to surgery
- Pregnancy
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 |
|---|---|---|
| Acetaminophen Oral TabletAlso: TylenolParticipants take 1000mg by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery. | Drug | Oral Acetaminophen 1000mg |
| placebo oral tabletParticipants take one placebo tablet (matchable to tylenol) by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery. | Drug | Intravenous Acetaminophen 1000mg |
| Acetaminophen infusionParticipants take 1000mg by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery. | Drug | Intravenous Acetaminophen 1000mg |
| Placebo infusionParticipants take 1000mg placebo by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery. | Drug | Oral Acetaminophen 1000mg |
Primary outcome
Numerical Rating Scale (NRS) Pain Intensity Scale Score
Time frame: postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours
Mean pain intensity scores post-operatively using 11-point Numerical Rating Scale (NRS) (scale ranges from 0 to 10, and higher score means higher pain)
10 secondary outcomes
Length of Hospital Stay
Time frame: After surgery until discharge, up to 10 days
Time to first ambulation after surgery
Time frame: After surgery until discharge, up to 10 days
Quality of Life (EuroQol Questionaire) scale score
Time frame: 48 hours, up to 1 month after surgery
Cumulative opioid consumption
Time frame: After surgery until discharge, up to 10 days
Healthcare cost during admission
Time frame: After surgery until discharge, up to 10 days
Number of participants with treatment-related hepatic toxicity
Time frame: postoperative time intervals: 2 hours(baseline), 24 hours, 48 hours
Number of participants with treatment-related skin rash
Time frame: After surgery until discharge, up to 10 days, whichever is first
Change in Patient Global Assessment Scale Score
Time frame: postoperative time intervals: 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours
Time to first additional opioid medication dose
Time frame: After surgery until discharge, up to 10 days
Total number of additional opioid medication doses
Time frame: After surgery until discharge, up to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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.
Atman Desai, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen Oral Tablet and Acetaminophen infusion in people with Postoperative Pain, run by Stanford University at 1 site in United States.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Numerical Rating Scale (NRS) Pain Intensity Scale Score (time frame: postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours). 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 8 Oct 2025.