Post-operative PainPhase 4NCT02069184
IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
A Phase 4 study testing IV Acetaminophen in people with Post-operative Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-operative Pain
- 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
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective full term CS patients
- Age 18 and above
- ASA I-III
Who cannot join
- Allergic reaction to IV acetaminophen
- Not able to understand and sign the research consent
- Pregnancy induced hypertension or pre-eclampsia patients
- Planned intensive care admission patients
- Patients with severe hepatic impairment or active liver diseases (Two fold increase in any of the liver enzymes)
- Patients with serum creatinine>2mg/dl
- For nursing mothers, any evidence of hepatic dysfunction of the new born
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center- Weiler
The Bronx, New York, 10467
About this study
Official title: Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.
Read the detailed description
Most of the opioids used are centrally acting drugs like morphine or its derivatives. The most common adverse reactions related to systemic administration of opioids are sedation, itching, constipation and less commonly, respiratory depression. One of the other management strategies for the pain control is the use of non-steroidal anti-inflammatory drugs (NSAIDS). Frequent use of NSAIDS is also associated with complications, such as gastric ulcer and platelet dysfunction. When compared to other non-NSAIDS, IV acetaminophen is a relatively safer drug with quicker onset of action. In an earlier conducted study, the onset of action of analgesia for a bolus dose of IV acetaminophen is 3 minutes. IV acetaminophen is FDA approved for management of mild to moderate pain. An adverse reaction associated with the prolonged usage of IV acetaminophen is hepatic injury. The most common adverse events encountered during previous clinical trials were nausea, vomiting, headache and insomnia.
- Conditions
- Post-operative Pain
- Being tested
- IV Acetaminophen, Saline as placebo
- Keywords
- opioid usage requirements, pain, IV acetaminophen, opioid usage, c-section
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
Also called IV Tylenol
1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly
Saline as placeboOther
100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
| Study group | Role | What they receive |
|---|---|---|
| IV Acetaminophen | Experimental | IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. Receives: Drug: IV Acetaminophen |
| Saline as placebo | Experimental | IV form, total 4 units, each given every 6th hourly in 24 hours. Receives: Other: Saline as placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Requirements in Cesarean Section (C-section) Patient Population
Measured: 24 and 48 hours after Cesarean Section
Secondary outcomes (6)
Visual Analog Score (VAS) Pain Score
Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst
Measured: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours
Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section
Sedation was assessed on a scale of 1-3 (1= wide awake, 2= sleepy but easily aroused, 3= sleepy and difficult to arouse). These assessments were made at the same time points as the pain assessments by the same research assistant. Score 1 is the only good outcome.
Measured: Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section
"Percentage of Patients With Adverse Events After the Surgery
Subjects were specifically asked about adverse events such as nausea, vomiting, pruritus and breathing difficulties and information regarding their bowel movements. This information was collected on a scale of none, mild, moderate or severe. These are categorical outcomes.
Measured: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge.
Number of Participants Using Patient-controlled Analgesia (PCA) Attempts
Data were not collected.The use of patient-controlled analgesia (PCA) pumps could have been utilized to standardize rescue medications. This would have allowed the collection of the proportion of subjects that required additional rescue medications. This was another possible endpoint that could have been evaluated.
Measured: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours.
Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge
No patients were re hospitalized in the first 7 days
Measured: From time of discharge to 1 week after discharge
Pain Medication Usage ( NSAIDS)
Compare the percentage of patients using non-opioid pain medication at 24 hours, and 48 hours and had experienced any adverse events.
Measured: For the first 24 hours after the c-section until the patient is discharged or up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Singh Nair, Montefiore Medical Center
- Investigators
- Jeffrey Bernstein, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069184
- Sponsor's protocol ID
- 13-07-144
- Status last verified
- Aug 2019
- First submitted
- 2 Dec 2013
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bernstein J, Spitzer Y, Ohaegbulam K, Reddy S, Song J, Romanelli E, Nair S. The analgesic efficacy of IV acetaminophen for acute postoperative pain in C-section patients: a randomized, double-blind, placebo-controlled study. J Matern Fetal Neonatal Med. 2022 Mar;35(5):933-940. doi: 10.1080/14767058.2020.1735337. Epub 2020 Mar 10.
PubMed 32156175
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded Randomized Placebo Controlled Study in Evaluating the Effectiveness of IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
- ClinicalTrials.gov ID
- NCT02069184
- Acronym / sponsor ID
- 13-07-144
- Conditions
- Post-operative Pain
- Keywords
- opioid usage requirements, pain, IV acetaminophen, opioid usage, c-section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Posted 22 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.
Detailed description
Most of the opioids used are centrally acting drugs like morphine or its derivatives. The most common adverse reactions related to systemic administration of opioids are sedation, itching, constipation and less commonly, respiratory depression. One of the other management strategies for the pain control is the use of non-steroidal anti-inflammatory drugs (NSAIDS). Frequent use of NSAIDS is also associated with complications, such as gastric ulcer and platelet dysfunction. When compared to other non-NSAIDS, IV acetaminophen is a relatively safer drug with quicker onset of action. In an earlier conducted study, the onset of action of analgesia for a bolus dose of IV acetaminophen is 3 minutes. IV acetaminophen is FDA approved for management of mild to moderate pain. An adverse reaction associated with the prolonged usage of IV acetaminophen is hepatic injury. The most common adverse events encountered during previous clinical trials were nausea, vomiting, headache and insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Acetaminophen | Experimental | Drug: IV AcetaminophenIV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. |
| Saline as placebo | Experimental | Other: Saline as placeboIV form, total 4 units, each given every 6th hourly in 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective full term CS patients
- Age 18 and above
- ASA I-III
Key exclusion criteria (7 listed)
- Allergic reaction to IV acetaminophen
- Not able to understand and sign the research consent
- Pregnancy induced hypertension or pre-eclampsia patients
- Planned intensive care admission patients
- Patients with severe hepatic impairment or active liver diseases (Two fold increase in any of the liver enzymes)
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: IV Tylenol1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly | Drug | IV Acetaminophen |
| Saline as placebo100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly. | Other | Saline as placebo |
Primary outcome
Opioid Requirements in Cesarean Section (C-section) Patient Population
Time frame: 24 and 48 hours after Cesarean Section
6 secondary outcomes
Visual Analog Score (VAS) Pain Score
Time frame: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours
Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section
Time frame: Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section
"Percentage of Patients With Adverse Events After the Surgery
Time frame: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge.
Number of Participants Using Patient-controlled Analgesia (PCA) Attempts
Time frame: every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours.
Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge
Time frame: From time of discharge to 1 week after discharge
Pain Medication Usage ( NSAIDS)
Time frame: For the first 24 hours after the c-section until the patient is discharged or up to 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32156175Bernstein J, Spitzer Y, Ohaegbulam K, Reddy S, Song J, Romanelli E, Nair S. The analgesic efficacy of IV acetaminophen for acute postoperative pain in C-section patients: a randomized, double-blind, placebo-controlled study. J Matern Fetal Neonatal Med. 2022 Mar;35(5):933-940. doi: 10.1080/14767058.2020.1735337. Epub 2020 Mar 10.
- 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.
Jeffrey Bernstein, MD principal investigator
Montefiore Medical Center
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 Post-operative Pain, run by Montefiore Medical Center 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 7 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 22 Aug 2019. 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 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 22 Aug 2019). 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?
Opioid Requirements in Cesarean Section (C-section) Patient Population (time frame: 24 and 48 hours after Cesarean Section). 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 NCT02069184, 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 22 Aug 2019.