Lung TumorPhase 4NCT01783236
Analgesic Efficacy of Intravenous Acetaminophen After Video-assisted Thoracic Surgery
A Phase 4 study testing IV Acetaminophen in people with Lung Tumor, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Tumor
- What is being tested?
- IV Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any elective VATS patients with low probability of conversion to thoracotomy as determined by surgery.
- Ages 18-99
- American Society of Anesthesiologists Physical Status I-III, hemodynamically stable
- Male or female
Who cannot join
- Age less than 18.
- Patient refusal
- High probability of conversion to thoracotomy as determined by surgeon
- Conversion of procedure to thoracotomy (subjects will be withdrawn if VATS procedure is converted to thoracotomy, as thoracotomy is more invasive and will likely require additional analgesia such as neuraxial and regional anesthesia).
- Scheduled procedure of VATS Pleurodesis/decortication
- History of Interstitial Lung Disease
Show all 16Show fewer
- Emergency case
- Known allergy/adverse reaction to acetaminophen, morphine, or fentanyl
- History of drug or alcohol abuse
- Patients on preoperative analgesic therapy within one week of surgery
- Contraindication to self administered morphine (unable to understand PCA)
- Need for postoperative mechanical ventilation
- Necessary major deviation for intraoperative study protocol as per the discretion of the intraoperative attending anesthesiologist
- History of congestive heart failure, renal failure, liver failure
- Pregnant or breastfeeding women
- Weight less than 51 kg
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Compare the Effectiveness of IV Acetaminophen Administered Intra-operatively in Reducing the Use of Opiates to Treat Post-operative Pain
We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
Read the detailed description
We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. One group of subjects will receive IV acetaminophen every six hours beginning within 30 minutes before surgical end time and continuing for 24 hours plus IV morphine PCA, and the other group will receive IV placebo every six hours plus IV morphine PCA, a standard treatment for postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
- Conditions
- Lung Tumor
- Being tested
- IV Acetaminophen, Saline Placebo
- Keywords
- VATS, thoracic surgery, acetaminophen, ofirmev, lung surgery, thoracoscopic, intravenous acetaminophen
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
Also called Ofirmev, Paracetamol
1000mg IV Ofirmev given every six hours for a total of four doses.
Saline PlaceboDrug
Also called Normal saline solution
Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.
| Study group | Role | What they receive |
|---|---|---|
| Saline Placebo | Placebo comparator | Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. Receives: Drug: Saline Placebo |
| IV Acetaminophen | Active comparator | Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. Receives: Drug: IV Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Morphine Consumption (mg)
How much morphine the subject consumes in the first 24 hours after surgery (mg).
Measured: 24 hours
Secondary outcomes (4)
Total Number of PCA Requests in First 24 Hours Post-Operation
The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation
Measured: 24 hours post-operation
VAS Pain Score 2 Hours Post Operation
2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).
Measured: 2 Hours Post Operation
VAS Pain Score 6 Hours Post-Operation
6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).
Measured: 6 Hours Post-Operation
VAS Score 24 Hours Post-Operation
24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled "No Pain" (score of 0) and "Worst possible pain" (score of 100).
Measured: 24 hours post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung TumorStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Hugh Hemmings, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783236
- Sponsor's protocol ID
- 1204012295
- Status last verified
- Mar 2017
- First submitted
- 31 Jan 2013
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Compare the Effectiveness of IV Acetaminophen Administered Intra-operatively in Reducing the Use of Opiates to Treat Post-operative Pain
- ClinicalTrials.gov ID
- NCT01783236
- Acronym / sponsor ID
- 1204012295
- Conditions
- Lung Tumor
- Keywords
- VATS, thoracic surgery, acetaminophen, ofirmev, lung surgery, thoracoscopic, intravenous acetaminophen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Jun 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Posted 11 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
Detailed description
We will study the efficacy of FDA approved intravenous (IV) acetaminophen ("Ofirmev", © 2011 Cadence Pharmaceuticals, Inc.) in reducing opioid consumption after minimally invasive thoracic surgery in a double blind randomized trial. This drug has been shown in Europe to reduce the need for patient controlled analgesia and the total dose of opioids, which have serious side effects in thoracic surgery patients. We will compare the use of IV patient-controlled morphine (PCA) in two groups of subjects in treating postoperative pain. One group of subjects will receive IV acetaminophen every six hours beginning within 30 minutes before surgical end time and continuing for 24 hours plus IV morphine PCA, and the other group will receive IV placebo every six hours plus IV morphine PCA, a standard treatment for postoperative pain. We will determine if IV acetaminophen reduces post-operative morphine requirements (primary end point). We will also assess subject pain scores and post-operative complications associated with pain management as secondary end points. Our hypothesis is that the study arm receiving intravenous acetaminophen will have lower total morphine consumptions compared to the placebo group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Placebo | Placebo comparator | Drug: Saline PlaceboSubjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours. |
| IV Acetaminophen | Active comparator | Drug: IV AcetaminophenSubjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any elective VATS patients with low probability of conversion to thoracotomy as determined by surgery.
- Ages 18-99
- American Society of Anesthesiologists Physical Status I-III, hemodynamically stable
- Male or female
Key exclusion criteria (16 listed)
- Age less than 18.
- Patient refusal
- High probability of conversion to thoracotomy as determined by surgeon
- Conversion of procedure to thoracotomy (subjects will be withdrawn if VATS procedure is converted to thoracotomy, as thoracotomy is more invasive and will likely require additional analgesia such as neuraxial and regional anesthesia).
- Scheduled procedure of VATS Pleurodesis/decortication
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 |
|---|---|---|
| IV AcetaminophenAlso: Ofirmev, Paracetamol1000mg IV Ofirmev given every six hours for a total of four doses. | Drug | IV Acetaminophen |
| Saline PlaceboAlso: Normal saline solutionNormal saline placebo given every six hours for a total of four doses if randomized to the placebo arm. | Drug | Saline Placebo |
Primary outcome
Total Morphine Consumption (mg)
Time frame: 24 hours
How much morphine the subject consumes in the first 24 hours after surgery (mg).
4 secondary outcomes
Total Number of PCA Requests in First 24 Hours Post-Operation
Time frame: 24 hours post-operation
VAS Pain Score 2 Hours Post Operation
Time frame: 2 Hours Post Operation
VAS Pain Score 6 Hours Post-Operation
Time frame: 6 Hours Post-Operation
VAS Score 24 Hours Post-Operation
Time frame: 24 hours post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Label information for acetaminophen (ofirmev)Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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.
Hugh Hemmings, MD, PhD principal investigator
Weill Medical College of Cornell 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 IV Acetaminophen in people with Lung Tumor, run by Weill Medical College of Cornell 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 4 inclusion and 16 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 11 May 2017. 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 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?
Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Morphine Consumption (mg) (time frame: 24 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 11 May 2017.