Pain, PostoperativePhase 3NCT04574778
Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy
A Phase 3 study testing Acetaminophen in people with Pain, Postoperative and Spine Surgery, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Spine Surgery
- What is being tested?
- Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 31 Oct 2024
- 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
- Age greater than 18 years-old
- Weight greater than 50 kg body weight
- ASA physical status I-III
- English-speaking
Who cannot join
- Weight less than 50 kg
- Pregnancy or breast feeding
- revision surgery
- Contraindications to the administration of acetaminophen (e.g. allergy, liver failure, etc)
- Chronic pain conditions unrelated to back pain
- Opioid tolerance ( defined as taking greater than oxycodone 20 mg daily for a week during the past month).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Thema Nicholson, MSc, 267-339-3615, thema.nicholson@rothmanortho.com
About this study
Official title: Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression
Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. The value of maintaining an efficient flow of patients from the perioperative area to discharge is an important metric for same day surgery centers, and an improvement in efficiency with IV acetaminophen could potentially offset the increased cost of the medication while providing a more pleasant surgical experience for patients. The goal of this study is to compare the efficacy of intraoperative IV administration vs. preoperative oral administration of acetaminophen on postoperative opioid utilization, patient-reported pain scores, opioid-related adverse effects, and time to recovery and discharge from the post-anesthesia care unit (PACU) after ambulatory lumbar discectomy.
- Conditions
- Pain, Postoperative, Spine Surgery
- Being tested
- Acetaminophen
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
1000 mg of oral acetaminophen preoperatively administered
| Study group | Role | What they receive |
|---|---|---|
| Group 1: IV acetaminophen and PO placebo | Active comparator | Group 1 will receive 1000 mg of IV acetaminophen approximately 30 minutes prior to skin closure and will receive oral placebo in the holding area prior to surgery Receives: Drug: Acetaminophen |
| Group 2: PO acetaminophen | Active comparator | Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo. Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid usage
Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents
Measured: 1 day
Secondary outcomes (3)
Quality of recovery
assessed using the Quality of Recovery 15 scale, with a range of 0-150 (0 is the worst score and 150 is the best possible recovery)
Measured: 1 day
Number of patients who report nausea or vomiting
this will be a count of the number of patients who report nausea or vomiting in recovery room
Measured: 1 day
Mean pain score
(0-10 numerical rating scale where 0=no pain and 10=worst pain imaginable) - this will be the mean pain rating upon entering pacu and at least 1 other time point in each study group
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start18 Mar 2021
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574778
- Sponsor's protocol ID
- GSCHR19D.660
- Status last verified
- Jan 2024
- First submitted
- 29 Sep 2020
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schwenk ES, Ferd P, Torjman MC, Li CJ, Charlton AR, Yan VZ, McCurdy MA, Kepler CK, Schroeder GD, Fleischman AN, Issa T. Intravenous versus oral acetaminophen for pain and quality of recovery after ambulatory spine surgery: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 10;50(6):483-488. doi: 10.1136/rapm-2024-105386.
PubMed 38499358
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression
- ClinicalTrials.gov ID
- NCT04574778
- Acronym / sponsor ID
- GSCHR19D.660
- Conditions
- Pain, Postoperative, Spine Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 5 Oct 2020 (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.
Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. The value of maintaining an efficient flow of patients from the perioperative area to discharge is an important metric for same day surgery centers, and an improvement in efficiency with IV acetaminophen could potentially offset the increased cost of the medication while providing a more pleasant surgical experience for patients. The goal of this study is to compare the efficacy of intraoperative IV administration vs. preoperative oral administration of acetaminophen on postoperative opioid utilization, patient-reported pain scores, opioid-related adverse effects, and time to recovery and discharge from the post-anesthesia care unit (PACU) after ambulatory lumbar discectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: IV acetaminophen and PO placebo | Active comparator | Drug: AcetaminophenGroup 1 will receive 1000 mg of IV acetaminophen approximately 30 minutes prior to skin closure and will receive oral placebo in the holding area prior to surgery |
| Group 2: PO acetaminophen | Active comparator | Drug: AcetaminophenGroup 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years-old
- Weight greater than 50 kg body weight
- ASA physical status I-III
- English-speaking
Key exclusion criteria (6 listed)
- Weight less than 50 kg
- Pregnancy or breast feeding
- revision surgery
- Contraindications to the administration of acetaminophen (e.g. allergy, liver failure, etc)
- Chronic pain conditions unrelated to back pain
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 |
|---|---|---|
| Acetaminophen1000 mg of oral acetaminophen preoperatively administered | Drug | Group 1: IV acetaminophen and PO placebo, Group 2: PO acetaminophen |
Primary outcome
Postoperative opioid usage
Time frame: 1 day
Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents
3 secondary outcomes
Quality of recovery
Time frame: 1 day
Number of patients who report nausea or vomiting
Time frame: 1 day
Mean pain score
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Derived from this study: PubMed 38499358Schwenk ES, Ferd P, Torjman MC, Li CJ, Charlton AR, Yan VZ, McCurdy MA, Kepler CK, Schroeder GD, Fleischman AN, Issa T. Intravenous versus oral acetaminophen for pain and quality of recovery after ambulatory spine surgery: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 10;50(6):483-488. doi: 10.1136/rapm-2024-105386.
- 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.
Rothman Orthopaedic Institute
Philadelphia, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetaminophen in people with Pain, Postoperative and Spine Surgery, run by Rothman Institute Orthopaedics 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid usage (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574778, which also lists 1 linked publication.
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 12 Jan 2024.