Postoperative PainNCT02216682
Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment
An observational study of Postoperative Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement with spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2017
- Phase
- Observational
- 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
Study population: 174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal anesthesia will be enrolled. Patients will be enrolled for the study the morning of their surgery. Subjects will randomly receive one of the three treatments. The study will be double blind, randomized; placebo controlled comparing PO and IV acetaminophen to each other and a control (placebo). At the time patients arrive in the PACU, Group 1 will receive IV 1 gram acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo; Group 3 will receive IV placebo and PO placebo.
Who may be able to join
- Patients undergoing total knee replacement
- Successful spinal placement
- ≥18 years old
Who cannot join
- Failed spinal anesthesia
- Chronic opiate users
- Liver disease patients
- Allergy/hypersensitivity to acetaminophen
- Patients with baseline dementia
- Patients weighing less than 50kg, history of alcohol dependence, renal impairment, opiate allergy, and pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement with spinal anesthesia.
Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid consumption, a lower percentage of patients rescuing, or a longer time to first rescue with IV acetaminophen. The investigators will compare the efficacies of oral and intravenous acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.
Read the detailed description
Intravenous acetaminophen has rapid onset and potent analgesic properties. Recent studies have shown several advantages of using intravenous acetaminophen perioperatively. However, due to its relatively high cost and limited clinical data concerning its efficacy compared with other agents, physicians are hesitant to use intravenous acetaminophen in the perioperative period.
174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal anesthesia will be enrolled. The study will be double blind, randomized; placebo controlled comparing oral and IV acetaminophen to each other and a control (placebo). At the time patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo; Group 3 will receive IV placebo and PO placebo.
The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate analgesia (total measured in milligrams) will be collected.
The difference in pain scores will be assessed by a chi-square test. A multivariable regression model will be performed with the clinical and statistically significant variables to remove confounding.
- Conditions
- Postoperative Pain
- Keywords
- Acetaminophen, Total knee replacement, Numeric rating scale
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores assessed and recorded by using the numeric rating scale
The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale, from 1-10, every 15 minutes.
Measured: Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.
Secondary outcomes (4)
Time to rescue analgesia
The amount of time after the surgery is completed until a patient receives rescue analgesia will be measured in minutes.
Measured: Participants will be followed for the duration of their hospital stay, an expected average of one week
Time to post-anesthesia care unit (PACU) discharge
The time from arrive in the PACU to discharge will be measured in minutes.
Measured: Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.
Opioid Use
The investigators will collect total amount of oral and/ or intravenous hydromorphone that is consumed by for adequate analgesia.
Measured: Participants will be followed for six hours postoperatively.
Postoperative nausea and vomiting
The investigators will collect information on postoperative nausea and vomiting.
Measured: Participants will be followed for six hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2017
- Study completionDec 2017
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 Postoperative PainStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 174 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
- Investigators
- Jingping Wang, MD, Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216682
- Sponsor's protocol ID
- 2014P001139
- Status last verified
- Sep 2017
- First submitted
- 11 Aug 2014
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Neal JB, Freiberg AA, Yelle MD, Jiang Y, Zhang C, Gu Y, Kong X, Jian W, O'Neal WT, Wang J. Intravenous vs Oral Acetaminophen as an Adjunct to Multimodal Analgesia After Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind Clinical Trial. J Arthroplasty. 2017 Oct;32(10):3029-3033. doi: 10.1016/j.arth.2017.05.019. Epub 2017 May 18.
PubMed 28690041
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment
- ClinicalTrials.gov ID
- NCT02216682
- Acronym / sponsor ID
- 2014P001139
- Conditions
- Postoperative Pain
- Keywords
- Acetaminophen, Total knee replacement, Numeric rating scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Aug 2014 (estimated)
- 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.
To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement with spinal anesthesia.
Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid consumption, a lower percentage of patients rescuing, or a longer time to first rescue with IV acetaminophen. The investigators will compare the efficacies of oral and intravenous acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.
Detailed description
Intravenous acetaminophen has rapid onset and potent analgesic properties. Recent studies have shown several advantages of using intravenous acetaminophen perioperatively. However, due to its relatively high cost and limited clinical data concerning its efficacy compared with other agents, physicians are hesitant to use intravenous acetaminophen in the perioperative period.
174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal anesthesia will be enrolled. The study will be double blind, randomized; placebo controlled comparing oral and IV acetaminophen to each other and a control (placebo). At the time patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo; Group 3 will receive IV placebo and PO placebo.
The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate analgesia (total measured in milligrams) will be collected.
The difference in pain scores will be assessed by a chi-square test. A multivariable regression model will be performed with the clinical and statistically significant variables to remove confounding.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal anesthesia will be enrolled. Patients will be enrolled for the study the morning of their surgery. Subjects will randomly receive one of the three treatments. The study will be double blind, randomized; placebo controlled comparing PO and IV acetaminophen to each other and a control (placebo). At the time patients arrive in the PACU, Group 1 will receive IV 1 gram acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo; Group 3 will receive IV placebo and PO placebo.
Key inclusion criteria (3 listed)
- Patients undergoing total knee replacement
- Successful spinal placement
- ≥18 years old
Key exclusion criteria (6 listed)
- Failed spinal anesthesia
- Chronic opiate users
- Liver disease patients
- Allergy/hypersensitivity to acetaminophen
- Patients with baseline dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain scores assessed and recorded by using the numeric rating scale
Time frame: Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.
The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale, from 1-10, every 15 minutes.
4 secondary outcomes
Time to rescue analgesia
Time frame: Participants will be followed for the duration of their hospital stay, an expected average of one week
Time to post-anesthesia care unit (PACU) discharge
Time frame: Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.
Opioid Use
Time frame: Participants will be followed for six hours postoperatively.
Postoperative nausea and vomiting
Time frame: Participants will be followed for six hours postoperatively.
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 15 Jun 2026.
- Derived from this study: PubMed 28690041O'Neal JB, Freiberg AA, Yelle MD, Jiang Y, Zhang C, Gu Y, Kong X, Jian W, O'Neal WT, Wang J. Intravenous vs Oral Acetaminophen as an Adjunct to Multimodal Analgesia After Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind Clinical Trial. J Arthroplasty. 2017 Oct;32(10):3029-3033. doi: 10.1016/j.arth.2017.05.019. Epub 2017 May 18.
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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.
Jingping Wang, MD, Ph.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, 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 3 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 15 Jun 2026. 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.
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?
Pain scores assessed and recorded by using the numeric rating scale (time frame: Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.). 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 NCT02216682, 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 15 Jun 2026.