Lumbar; InjuryPhase 2NCT05764707
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery
A Phase 2 study testing Acetaminophen in people with Lumbar; Injury, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar; Injury
- What is being tested?
- Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 3 Feb 2023
- Phase
- Phase 2
- 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
- Patients undergoing 1-2 levels primary spine surgery ≥18 years old
Who cannot join
- Chronic opiate users
- More than 3 levels or revision spine surgery
- Liver disease patients include elevated LFT, hepatitis A, hepatitis B or hepatitis C, cirrhosis, fatty liver disease, and any other liver diseases caused by drugs, poisons, or alcohol(s)
- Allergy/hypersensitivity to acetaminophen
- Patients that have used acetaminophen during the 24 hours before their scheduled surgery
- Subjects who were unable to communicate in English were further excluded because of their inability to complete the postoperative questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02214
About this study
Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.
- Conditions
- Lumbar; Injury
- Being tested
- Acetaminophen, Placebo
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
Patients will received 1000mg of intravenous acetaminophen within 30 minutes of skin closure.
PlaceboDrug
Also called Normal Saline
Patients will received 1000mg of normal saline within 30 minutes of skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Acetaminophen | Experimental | Intravenous acetaminophen (1000mg) will be administered within 30 minutes of skin closure. Receives: Drug: Acetaminophen |
| Intravenous Placebo | Placebo comparator | Intravenous normal saline will be administered within 30 minutes of skin closure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst pain score in the post-anesthesia care unit
The primary outcome will assess worst pain score at the time the patient is ready for post anesthesia care unit discharge using the Revised American Pain Society Patient Outcome Questionnaire. This scale ranges from 0 to 10, with higher values reporting more pain.
Measured: Time of postoperative care unit discharge readiness, approximately 3 hours
Secondary outcomes (7)
Postoperative pain scores
Pain scores will be collected for the first 72 hours or up until discharge, whichever comes first, using clinically documented nursing pain scores. Values will be collected on a scale from 0 to 10 with higher values indicating increased (worst) pain.
Measured: Postoperatively until 72 hours or discharge, approximately three days
Intraoperative opioid consumption
Total cumulative morphine equivalents will be reported while the patient is in the operating room.
Measured: Intraoperatively
Postoperative opioid consumption in the post anesthesia care unit
Total cumulative morphine equivalents will be reported while the patient is in the post anesthesia care unit.
Measured: Postoperatively until time of PACU discharge, approximately 3 hours.
Postoperative opioid consumption after discharge from the postoperative care
Total cumulative morphine equivalents will be reported starting from the time the patient is discharged from the post anesthesia care unit until they are discharged from the hospital.
Measured: Time of discharge from the postoperative care unit until discharge from the hospital, an average of two days
Time to rescue analgesia
The time to rescue analgesia (in minutes) will be assessed.
Measured: Postoperatively until discharge, an average of two days
Patient satisfaction
Satisfaction with the patient's pain treatment in the hospital will be assessed at the time the patient is ready for discharge from the post anesthesia care unit using the Revised American Pain Society Patient Outcome Questionnaire. This scale ranges from 0 (extremely dissatisfied) to 10 (extremely satisfied).
Measured: Time of postoperative care unit discharge readiness, approximately 3 hours.
Length of hospital stay
Length of hospital stay (in days) will be reported.
Measured: Postoperatively until discharge, an average of two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start10 Jan 2020
- Primary completion31 Jan 2023
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar; InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingping Wang, MD, Ph.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764707
- Sponsor's protocol ID
- 2019P002750
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery
- ClinicalTrials.gov ID
- NCT05764707
- Acronym / sponsor ID
- 2019P002750
- Conditions
- Lumbar; Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 13 Mar 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.
Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Acetaminophen | Experimental | Drug: AcetaminophenIntravenous acetaminophen (1000mg) will be administered within 30 minutes of skin closure. |
| Intravenous Placebo | Placebo comparator | Drug: PlaceboIntravenous normal saline will be administered within 30 minutes of skin closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing 1-2 levels primary spine surgery ≥18 years old
Key exclusion criteria (6 listed)
- Chronic opiate users
- More than 3 levels or revision spine surgery
- Liver disease patients include elevated LFT, hepatitis A, hepatitis B or hepatitis C, cirrhosis, fatty liver disease, and any other liver diseases caused by drugs, poisons, or alcohol(s)
- Allergy/hypersensitivity to acetaminophen
- Patients that have used acetaminophen during the 24 hours before their scheduled surgery
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 |
|---|---|---|
| AcetaminophenAlso: TylenolPatients will received 1000mg of intravenous acetaminophen within 30 minutes of skin closure. | Drug | Intravenous Acetaminophen |
| PlaceboAlso: Normal SalinePatients will received 1000mg of normal saline within 30 minutes of skin closure. | Drug | Intravenous Placebo |
Primary outcome
Worst pain score in the post-anesthesia care unit
Time frame: Time of postoperative care unit discharge readiness, approximately 3 hours
The primary outcome will assess worst pain score at the time the patient is ready for post anesthesia care unit discharge using the Revised American Pain Society Patient Outcome Questionnaire. This scale ranges from 0 to 10, with higher values reporting more pain.
7 secondary outcomes
Postoperative pain scores
Time frame: Postoperatively until 72 hours or discharge, approximately three days
Intraoperative opioid consumption
Time frame: Intraoperatively
Postoperative opioid consumption in the post anesthesia care unit
Time frame: Postoperatively until time of PACU discharge, approximately 3 hours.
Postoperative opioid consumption after discharge from the postoperative care
Time frame: Time of discharge from the postoperative care unit until discharge from the hospital, an average of two days
Time to rescue analgesia
Time frame: Postoperatively until discharge, an average of two days
Patient satisfaction
Time frame: Time of postoperative care unit discharge readiness, approximately 3 hours.
Length of hospital stay
Time frame: Postoperatively until discharge, an average of two days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetaminophen in people with Lumbar; Injury, run by Massachusetts General Hospital 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 1 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: finished, as of the sponsor's last update on 12 Feb 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Worst pain score in the post-anesthesia care unit (time frame: Time of postoperative care unit discharge readiness, approximately 3 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 12 Feb 2024.