Postoperative PainPhase 4NCT01798316
IV Acetaminophen for Postoperative Analgesia
A Phase 4 study testing IV Acetaminophen in people with Postoperative Pain and Postoperative Nausea, run by Northwell Health at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea, Postoperative Vomiting
- What is being tested?
- IV Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2013to Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
- American Society of Anesthesiology patient classification status I-II
Who cannot join
- Regular preoperative use of or opioids,
- Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
- Subjects converted to open laparoscopic cholecystectomy
- Known allergy/hypersensitivity to acetaminophen
- Use of opioids prior to commencement of the study (<7 days)
- Patients with chronic pain conditions or disease requiring pain control
Show all 11Show fewer
- Abnormal liver function
- Known or suspected alcohol, drug or opiate abuse or dependence
- Patients with a BMI of greater than 35
- Other physical, mental or medical conditions that could effect participation.
- Abnormal renal function; serum creatinine>2gm/dl
Trial locations and contacts
3 sites in 1 country.
United States3 sites
North Shore University Hospital
Manhasset, New York, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Syosset Hospital
Syosset, New York, 11791
About this study
Official title: IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy
The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.
Read the detailed description
The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.
- Being tested
- IV Acetaminophen, Standard of Care
- Keywords
- IV Acetaminophen, Laparoscopic cholecystectomy, Postoperative nausea, Postoperative vomiting
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
Also called Ofirmev
Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen
Standard of CareDrug
Also called As per provider: Opioids
Standard of care pain management regimen, no IV Acetaminophen,
| Study group | Role | What they receive |
|---|---|---|
| IV Acetaminophen | Active comparator | IV Acetaminophen administered on admission to post-anesthesia care unit Receives: Drug: IV Acetaminophen |
| Standard of care | Active comparator | Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Postoperative Nausea and Vomiting (PONV).
Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay.
PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.
Measured: 4 hours plus/minus 30 minutes
Secondary outcomes (4)
Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery.
PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge.
Measured: Up to two days following surgery
Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.
Measured: 4 hours plus/minus 30 minutes
Patient Satisfaction on a 5 Point Likert Scale
Number of patients very satisfied or satisfied with pain and PONV management during hospital stay
Measured: Up to one week following surgery
Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities
Measured: 1 hour following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Principal Investigator left the institution
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 Postoperative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank J Overdyk, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798316
- Sponsor's protocol ID
- 12-0409
- Other IDs
- IRB #12-409B
- Status last verified
- May 2017
- First submitted
- 5 Feb 2013
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01798316
- Acronym / sponsor ID
- 12-0409
- Keywords
- IV Acetaminophen, Laparoscopic cholecystectomy, Postoperative nausea, Postoperative vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left the institution
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.
Detailed description
The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Acetaminophen | Active comparator | Drug: IV AcetaminophenIV Acetaminophen administered on admission to post-anesthesia care unit |
| Standard of care | Active comparator | Drug: Standard of CareStandard of care pain management regimen including opioids administered on admission to post-anesthesia care unit |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
- American Society of Anesthesiology patient classification status I-II
Key exclusion criteria (11 listed)
- Regular preoperative use of or opioids,
- Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
- Subjects converted to open laparoscopic cholecystectomy
- Known allergy/hypersensitivity to acetaminophen
- Use of opioids prior to commencement of the study (<7 days)
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: OfirmevSingle dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen | Drug | IV Acetaminophen |
| Standard of CareAlso: As per provider: OpioidsStandard of care pain management regimen, no IV Acetaminophen, | Drug | Standard of care |
Primary outcome
Number of Participants With Postoperative Nausea and Vomiting (PONV).
Time frame: 4 hours plus/minus 30 minutes
Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.
4 secondary outcomes
Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
Time frame: Up to two days following surgery
Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
Time frame: 4 hours plus/minus 30 minutes
Patient Satisfaction on a 5 Point Likert Scale
Time frame: Up to one week following surgery
Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
Time frame: 1 hour following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Frank J Overdyk, MD principal investigator
Northwell Health
3 sites 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 Postoperative Pain and Postoperative Nausea, run by Northwell Health at 3 sites 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 2 inclusion and 11 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: stopped early, as of the sponsor's last update on 31 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 3 sites 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?
Yes. Results are posted in the registry (first posted 31 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?
Number of Participants With Postoperative Nausea and Vomiting (PONV). (time frame: 4 hours plus/minus 30 minutes). 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 31 May 2017.