Postoperative PainPhase 4NCT04290208
A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section
A Phase 4 study testing Acetaminophen in people with Postoperative Pain and Cesarean Section, run by Main Line Health at 1 site in United States.
Trial summary
This randomized controlled study will compare narcotic consumption between two groups: patients that receive a perioperative dose of IV acetaminophen versus patients that receive a perioperative dose of oral liquid acetaminophen for scheduled cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Cesarean Section, Acetaminophen
- What is being tested?
- Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2019to 23 Jun 2020
- Phase
- Phase 4
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women age 18 or older
- Scheduled to undergo a cesarean section
Who cannot join
- Existing diagnosis of chronic pain
- Need to undergo a vertical skin incision
- Aspartate Aminotransferase (AST) > 50, alanine aminotransferase (ALT) > 70
- Platelets below 80,000 on admission
- Need to undergo general anesthesia
- Tubal ligation at time of Cesarean section
- Prior or known allergy to any of the medications being utilized in this study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Derek Bowden, 484-476-2692, Dbowden@mlhs.org
About this study
This randomized controlled study will compare narcotic consumption between two groups: patients that receive a perioperative dose of IV acetaminophen versus patients that receive a perioperative dose of oral liquid acetaminophen for scheduled cesarean section.
Read the detailed description
"Enhanced recovery" is an alternate management protocol described by a multi-modal, evidence based approach to peri-operative care, with the goal of accelerating recovery and return to normal activity after surgery. Results have shown stable pain control with a decrease in narcotic consumption, a quicker return of bowel function, and decreased length of hospital stay and cost with no change in level of patient satisfaction, morbidity, or readmission rate. An aspect of some alternate management protocols is the administration of acetaminophen.
The concentration of acetaminophen in cerebrospinal fluid (CSF) is directly proportional to the analgesic activity of acetaminophen. Acetaminophen relies on a high concentration gradient from the plasma to the CSF in order to passively diffuse into the central nervous system (CNS), its principal site of action. A 2012 study, comparing plasma and CSF pharmacokinetics of intravenous (IV), oral (PO), or rectal (PR) acetaminophen, concluded that IV administration of acetaminophen results in higher plasma and CSF concentration values. Therefore, IV acetaminophen produces better CNS penetration compared to PO or PR methods.
- Conditions
- Postoperative Pain, Cesarean Section, Acetaminophen
- Being tested
- Acetaminophen, Placebos
- Keywords
- Humans, Female, Pregnancy, Acetaminophen, Narcotics, Patient Satisfaction, Cesarean Section, Pain, Postoperative Period
- Medical subject headings
- Pain, Postoperative, Patient Satisfaction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
IV Acetaminophen
AcetaminophenDrug
Also called Tylenol
Acetaminophen liquid syrup
PlacebosDrug
Also called Placebo for acetaminophen
Flavored, non-medicated (placebo) liquid syrup
PlacebosDrug
Also called Placebo for acetaminophen
IV salt solution (non-medicated)
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Administration of Acetaminophen | Active comparator | A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed. Receives: Drug: Acetaminophen; Drug: Placebos |
| Per Oral Administration of Acetaminophen | Active comparator | A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room. Receives: Drug: Acetaminophen; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic Utilization
The Center for Disease Control and Prevention Morphine Milligram Equivalent Score will be used to calculate total narcotic use (conversion factor for administered opioid x milligrams administered) while the patient remains as an inpatient.
Measured: 6 hours post operative
Secondary outcomes (3)
Post-operative Pain Level
Pain will be measured via the visual analog Postoperative Pain Scale and gathered by nursing. The visual analogue Postoperative Pain Scale indicates the level of pain the patient is feeling or felt in the indicated period from 0 (no pain) to 100 (the worst pain possible).
Measured: Every hour for six hours post-op
Patient Satisfaction
Patient satisfaction will be assessed using the validated survey used in the Mayo Clinical Trial.
Measured: Up to 24 hours
Postoperative complications during the inpatient stay
Postoperative complications will be noted during the inpatient stay.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start22 Aug 2019
- Primary completion23 Jun 2020 (estimated)
- Study completion23 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation
- Responsible party
- Principal investigator, Dmitri Chamchad, Main Line Health
- Investigators
- Dmitri Chamchad, MD, Principal investigator, Main Line HealthRobert Day, MD, Principal investigator, Bryn Mawr Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290208
- Sponsor's protocol ID
- F/N-R19-3892BLP
- Status last verified
- Feb 2020
- First submitted
- 14 Aug 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nelson G, Kalogera E, Dowdy SC. Enhanced recovery pathways in gynecologic oncology. Gynecol Oncol. 2014 Dec;135(3):586-94. doi: 10.1016/j.ygyno.2014.10.006. Epub 2014 Oct 12.
PubMed 25316179Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.
PubMed 22524979
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section
- ClinicalTrials.gov ID
- NCT04290208
- Acronym / sponsor ID
- F/N-R19-3892BLP
- Conditions
- Postoperative Pain, Cesarean Section, Acetaminophen
- Keywords
- Humans, Female, Pregnancy, Acetaminophen, Narcotics, Patient Satisfaction, Cesarean Section, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 23 Jun 2020 (estimated)
- Study completion
- 23 Jun 2020 (estimated)
- First posted
- 28 Feb 2020 (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.
This randomized controlled study will compare narcotic consumption between two groups: patients that receive a perioperative dose of IV acetaminophen versus patients that receive a perioperative dose of oral liquid acetaminophen for scheduled cesarean section.
Detailed description
"Enhanced recovery" is an alternate management protocol described by a multi-modal, evidence based approach to peri-operative care, with the goal of accelerating recovery and return to normal activity after surgery. Results have shown stable pain control with a decrease in narcotic consumption, a quicker return of bowel function, and decreased length of hospital stay and cost with no change in level of patient satisfaction, morbidity, or readmission rate. An aspect of some alternate management protocols is the administration of acetaminophen.
The concentration of acetaminophen in cerebrospinal fluid (CSF) is directly proportional to the analgesic activity of acetaminophen. Acetaminophen relies on a high concentration gradient from the plasma to the CSF in order to passively diffuse into the central nervous system (CNS), its principal site of action. A 2012 study, comparing plasma and CSF pharmacokinetics of intravenous (IV), oral (PO), or rectal (PR) acetaminophen, concluded that IV administration of acetaminophen results in higher plasma and CSF concentration values. Therefore, IV acetaminophen produces better CNS penetration compared to PO or PR methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Administration of Acetaminophen | Active comparator | Drug: Acetaminophen, Drug: PlacebosA single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed. |
| Per Oral Administration of Acetaminophen | Active comparator | Drug: Acetaminophen, Drug: PlacebosA pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women age 18 or older
- Scheduled to undergo a cesarean section
Key exclusion criteria (7 listed)
- Existing diagnosis of chronic pain
- Need to undergo a vertical skin incision
- Aspartate Aminotransferase (AST) > 50, alanine aminotransferase (ALT) > 70
- Platelets below 80,000 on admission
- Need to undergo general anesthesia
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: TylenolIV Acetaminophen | Drug | Intravenous Administration of Acetaminophen |
| AcetaminophenAlso: TylenolAcetaminophen liquid syrup | Drug | Per Oral Administration of Acetaminophen |
| PlacebosAlso: Placebo for acetaminophenFlavored, non-medicated (placebo) liquid syrup | Drug | Intravenous Administration of Acetaminophen |
| PlacebosAlso: Placebo for acetaminophenIV salt solution (non-medicated) | Drug | Per Oral Administration of Acetaminophen |
Primary outcome
Narcotic Utilization
Time frame: 6 hours post operative
The Center for Disease Control and Prevention Morphine Milligram Equivalent Score will be used to calculate total narcotic use (conversion factor for administered opioid x milligrams administered) while the patient remains as an inpatient.
3 secondary outcomes
Post-operative Pain Level
Time frame: Every hour for six hours post-op
Patient Satisfaction
Time frame: Up to 24 hours
Postoperative complications during the inpatient stay
Time frame: Up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Background: PubMed 25316179Nelson G, Kalogera E, Dowdy SC. Enhanced recovery pathways in gynecologic oncology. Gynecol Oncol. 2014 Dec;135(3):586-94. doi: 10.1016/j.ygyno.2014.10.006. Epub 2014 Oct 12.
- Results publication: PubMed 22524979Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.
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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.
Dmitri Chamchad, MD principal investigator
Main Line Health
Robert Day, MD principal investigator
Bryn Mawr Hospital
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 Acetaminophen in people with Postoperative Pain and Cesarean Section, run by Main Line Health 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 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitri Chamchad, MD (610-355-9451, chamchad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narcotic Utilization (time frame: 6 hours post operative). 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 NCT04290208, which also lists 2 linked publications.
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 28 Feb 2020.