Inguinal HerniaPhase 4NCT03558555
Determine the Clinical Advantage of IV vs PO Acetaminophen
A Phase 4 study testing Acetaminophen IV Soln, Oral Acetaminophen and Saline in people with Inguinal Hernia, run by Yan Lai at 1 site in United States.
Trial summary
There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Acetaminophen IV Soln, Oral Acetaminophen and Saline
- 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
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2017to 30 Dec 2018
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA scores I-III
- Ambulatory surgery patients
- Ages 18-75
- Surgeries requiring general anesthesia for hernia surgery
Who cannot join
- Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
- Known allergy to acetaminophen
- Emergency surgery
- Patients who were not fasted
- Patients who cannot tolerate PO
- Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
Show all 11Show fewer
- Pregnancy
- Weight less than 50kg
- Chronic daily narcotic use
- Patients who's anesthetic plan requires regional anesthesia
- Patient refusal to participate or do not have capacity to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery
There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.
Read the detailed description
In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.
- Conditions
- Inguinal Hernia
- Being tested
- Acetaminophen IV Soln, Oral Acetaminophen, Placebo Pills, Saline
- Keywords
- Acetaminophen, Tylenol, Intravenous versus oral
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen IV SolnDrug
1000mg of IV acetaminophen
Oral AcetaminophenDrug
oral acetaminophen 975mg pills
Placebo PillsDrug
placebo match to acetaminophen
SalineDrug
Intravenous saline
| Study group | Role | What they receive |
|---|---|---|
| Oral Acetaminophen | Active comparator | Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively. Receives: Drug: Oral Acetaminophen; Drug: Saline |
| Acetaminophen IV Soln | Active comparator | Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively. Receives: Drug: Acetaminophen IV Soln; Drug: Placebo Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
PACU Visual Analogue Pain Scores
Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.
Measured: baseline, 1 hour, and Day 1 discharge
Total MME Intraoperatively
Total Morphine Milligram Equivalent (MME) use intraoperatively
Measured: Day 1
Total Narcotic Use in PACU.
Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)
Measured: Day 1
Secondary outcomes (3)
PACU Length of Stay
Time in PACU
Measured: up to 24 hours after PACU arrival
Patient Reported Total Narcotic Use Post-discharge
home opiod use
Measured: average 7 days
Patient Satisfaction.
Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction
Measured: 7 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start8 Dec 2017
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
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 (4)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies 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
- Model description
- Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yan Lai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Lai, Icahn School of Medicine at Mount Sinai
- Investigators
- Yan Lai, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558555
- Sponsor's protocol ID
- GCO 16-1763
- Other IDs
- IF#16-1763, IF#2175834
- Status last verified
- Jan 2020
- First submitted
- 4 Jun 2018
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.
PubMed 28742427Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.
PubMed 15790675Olbrecht VA, Ding L, Spruance K, Hossain M, Sadhasivam S, Chidambaran V. Intravenous Acetaminophen Reduces Length of Stay Via Mediation of Postoperative Opioid Consumption After Posterior Spinal Fusion in a Pediatric Cohort. Clin J Pain. 2018 Jul;34(7):593-599. doi: 10.1097/AJP.0000000000000576.
PubMed 29200016Patel A, Pai B H P, Diskina D, Reardon B, Lai YH. Comparison of clinical outcomes of acetaminophen IV vs PO in the peri-operative setting for laparoscopic inguinal hernia repair surgeries: A triple-blinded, randomized controlled trial. J Clin Anesth. 2020 May;61:109628. doi: 10.1016/j.jclinane.2019.109628. Epub 2019 Oct 25.
PubMed 31669049
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT03558555
- Acronym / sponsor ID
- GCO 16-1763
- Conditions
- Inguinal Hernia
- Keywords
- Acetaminophen, Tylenol, Intravenous versus oral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Yan LaiUniversity, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 10 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.
Detailed description
In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants presenting for inguinal hernia surgery are assigned to either the oral or intravenous acetaminophen group
| Arm | Type | Receives |
|---|---|---|
| Oral Acetaminophen | Active comparator | Drug: Oral Acetaminophen, Drug: SalinePatients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively. |
| Acetaminophen IV Soln | Active comparator | Drug: Acetaminophen IV Soln, Drug: Placebo PillsPatients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA scores I-III
- Ambulatory surgery patients
- Ages 18-75
- Surgeries requiring general anesthesia for hernia surgery
Key exclusion criteria (11 listed)
- Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
- Known allergy to acetaminophen
- Emergency surgery
- Patients who were not fasted
- Patients who cannot tolerate PO
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 |
|---|---|---|
| Acetaminophen IV Soln1000mg of IV acetaminophen | Drug | Acetaminophen IV Soln |
| Oral Acetaminophenoral acetaminophen 975mg pills | Drug | Oral Acetaminophen |
| Placebo Pillsplacebo match to acetaminophen | Drug | Acetaminophen IV Soln |
| SalineIntravenous saline | Drug | Oral Acetaminophen |
Primary outcome
PACU Visual Analogue Pain Scores
Time frame: baseline, 1 hour, and Day 1 discharge
Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.
Total MME Intraoperatively
Time frame: Day 1
Total Morphine Milligram Equivalent (MME) use intraoperatively
Total Narcotic Use in PACU.
Time frame: Day 1
Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)
3 secondary outcomes
PACU Length of Stay
Time frame: up to 24 hours after PACU arrival
Patient Reported Total Narcotic Use Post-discharge
Time frame: average 7 days
Patient Satisfaction.
Time frame: 7 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28742427Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. A Comparison of Multimodal Analgesic Approaches in Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery: Pharmacological Agents. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):903-908. doi: 10.1089/lap.2017.0338. Epub 2017 Jul 25.
- Background: PubMed 15790675Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.
- Background: PubMed 29200016Olbrecht VA, Ding L, Spruance K, Hossain M, Sadhasivam S, Chidambaran V. Intravenous Acetaminophen Reduces Length of Stay Via Mediation of Postoperative Opioid Consumption After Posterior Spinal Fusion in a Pediatric Cohort. Clin J Pain. 2018 Jul;34(7):593-599. doi: 10.1097/AJP.0000000000000576.
- Results publication: PubMed 31669049Patel A, Pai B H P, Diskina D, Reardon B, Lai YH. Comparison of clinical outcomes of acetaminophen IV vs PO in the peri-operative setting for laparoscopic inguinal hernia repair surgeries: A triple-blinded, randomized controlled trial. J Clin Anesth. 2020 May;61:109628. doi: 10.1016/j.jclinane.2019.109628. Epub 2019 Oct 25.
- 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.
Yan Lai, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
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 IV Soln, Oral Acetaminophen and Saline in people with Inguinal Hernia, run by Yan Lai 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 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: finished, as of the sponsor's last update on 10 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?
Yes. Results are posted in the registry (first posted 10 Feb 2020). 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?
PACU Visual Analogue Pain Scores (time frame: baseline, 1 hour, and Day 1 discharge). The study lists 3 primary outcomes in all. 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 NCT03558555, which also lists 4 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 10 Feb 2020.