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IV Acetaminophen for Postoperative Pain (IV APAP Trial)

N/A

Waitlist Available

Research Sponsored by McLaren Regional Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who are scheduled to undergo laparoscopic Roux-en-Y gastric bypass surgery (LRYGBP) under general anesthesia

Age 18 to 65 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 2 hours, 30 hours from first dose of study agent

Awards & highlights

IV APAP Trial Summary

This trial is testing whether giving acetaminophen before and after surgery can reduce a patient's post-operative pain and nausea, allowing them to recover bowel function sooner and go home sooner.

Who is the study for?

This trial is for adults aged 18-65 with a BMI over 35 who are scheduled for laparoscopic Roux-en-Y gastric bypass surgery. Participants must understand the study and how to use pain/nausea scales. Exclusions include known allergies to acetaminophen or opioids, recent opioid use, chronic pain conditions, significant liver disease, substance abuse issues, or participation in another study within the last month.Check my eligibility

What is being tested?

The trial tests if IV acetaminophen before and after surgery can reduce opioid use for pain relief post-surgery in LRYGBP patients. It aims to see if this leads to less nausea/vomiting, quicker bowel function recovery, faster progression to oral intake and shorter hospital stays compared to using normal saline.See study design

What are the potential side effects?

While not explicitly stated here, common side effects of IV acetaminophen may include nausea, headache, constipation; rare but serious reactions could involve skin rash/allergies or liver damage especially at high doses.

IV APAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific weight loss surgery under general anesthesia.

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I am between 18 and 65 years old.

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My BMI is over 35.

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I am not pregnant.

IV APAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2 hours, 30 hours from first dose of study agent

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 2 hours, 30 hours from first dose of study agent

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 hours, 30 hours from first dose of study agent for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

difference in post-operative opiate consumption (PCA)

Secondary outcome measures

acceptance of rescue medication

post-operative nausea and vomiting (PONV)

post-operative subjective pain intensity

+4 more

IV APAP Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: IV acetaminophenActive Control1 Intervention

Group II: IV 0.9% normal salinePlacebo Group1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

McLaren Regional Medical CenterLead Sponsor

1 Previous Clinical Trials

91 Total Patients Enrolled

Cadence PharmaceuticalsIndustry Sponsor

4 Previous Clinical Trials

2,029 Total Patients Enrolled

Christina Lee, B.Sc.Study DirectorMcLaren Regional Medical Center

Media Library

IV Acetaminophen (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01460667 — N/A

Obesity Research Study Groups: IV acetaminophen, IV 0.9% normal saline

Obesity Clinical Trial 2023: IV Acetaminophen Highlights & Side Effects. Trial Name: NCT01460667 — N/A

IV Acetaminophen (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01460667 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical ailments can be alleviated by intravenous acetaminophen?

"Intravenous acetaminophen can provide relief for catarrh, rhinorrhea and muscle-related pains."

Answered by AI

What previous investigations have focused on the efficacy of intravenous acetaminophen?

"Currently, 90 medical studies are investigating the effectiveness of intravenous acetaminophen. Of those, 27 trials have progressed to Phase 3. Despite most research being conducted in Pittsburgh, Pennsylvania, 1004 sites across the world are recruiting patients for this treatment."

Answered by AI

Is this trial still accepting enrollees?

"This clinical research is no longer enrolling participants. First posted on October 1st 2011, the trial's last edit was made on October 26th 2011. If you're looking for other medical trials, there are presently 577 studies concerning obesity and morbidity in addition to 90 clinical tests searching for patients that can receive IV acetaminophen treatments."

Answered by AI

What criteria must individuals meet to participate in this research trial?

"This trial has space for 85 individuals aged 18 to 65 with obesity (BMI >35) who are set to have laparoscopic Roux-en-Y gastric bypass surgery under general anaesthesia. In addition, they should be able to comprehend and use scales of pain and nausea effectively, as well as possess an ASA score of 1, 2 or 3. Also, women in their childbearing years must provide a negative pregnancy test result before being admitted into the study."

Answered by AI

How many participants are being administered this treatment regimen?

"This clinical trial has ceased its patient recruitment process, having initially opened on October 1st 2011 and been last amended on the 26th of that same month. However, there are 577 trials actively enrolling individuals with obesity or morbidity as well as 90 studies looking for patients to receive intravenous acetaminophen treatment."

Answered by AI

Does this research require participants to have surpassed the age of sixty?

"This trial is restricted to participants between 18-65 years of age. However, there are 106 trials targeting those under 18 and 500 for seniors over 65."

Answered by AI

Recent research and studies

Clinical TherapeuticsJournal

A Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of Two Intravenous Acetaminophen Dosing Regimens for the Treatment of Pain After Abdominal Laparoscopic Surgery

Wininger, Steven J., Howard Miller, Harold S. Minkowitz, Mike A. Royal, Robert Y. Ang, James B. Breitmeyer, and Neil K. Singla. 2010. “A Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of Two Intravenous Acetaminophen Dosing Regimens for the Treatment of Pain After Abdominal Laparoscopic Surgery”. Clinical Therapeutics. Elsevier BV. doi:10.1016/j.clinthera.2010.12.011.

Acta Anaesthesiologica ScandinavicaJournal

Efficacy and Safety of Patient-controlled Opioid Analgesia for Acute Postoperative Pain

Walder, B., M. Schafer, I. Henzi, and M. R. Tramèr. 2001. “Efficacy and Safety of Patient-controlled Opioid Analgesia for Acute Postoperative Pain”. Acta Anaesthesiologica Scandinavica. Wiley. doi:10.1034/j.1399-6576.2001.045007795.x.

Obesity SurgeryJournal

Inpatient Pain Medication Requirements After Laparoscopic Gastric Bypass

Madan, Atul K, Craig A Ternovits, Karen E Speck, and David S Tichansky. 2005. “Inpatient Pain Medication Requirements After Laparoscopic Gastric Bypass”. Obesity Surgery. Springer Science and Business Media LLC. doi:10.1381/0960892054222812.

Pain PracticeJournal