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Analgesic

Acetaminophen for Postoperative Pain

Phase 3
Recruiting
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ASA physical status I-III
Age greater than 18 years-old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Study Summary

This trial will compare IV and oral acetaminophen to reduce pain and opioid use during ambulatory surgery to help speed up patient discharge.

Who is the study for?
This trial is for English-speaking adults over 18 years old, weighing more than 50 kg, with a physical status classified as ASA I-III. It's not for pregnant or breastfeeding individuals, those under 50 kg, with a history of revision surgery, acetaminophen contraindications like allergies or liver failure, unrelated chronic pain conditions, or opioid tolerance.Check my eligibility
What is being tested?
The study compares the effectiveness of IV acetaminophen given during surgery versus oral acetaminophen taken before surgery in reducing postoperative pain and opioid use after ambulatory lumbar discectomy. It also looks at how these methods affect recovery time and discharge from the PACU.See study design
What are the potential side effects?
While not explicitly listed in the provided information, common side effects of acetaminophen may include nausea, itching, rash; serious but rare effects can be skin reactions and liver damage when taken in high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My health is good to moderately impaired.
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I am older than 18 years.
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I weigh more than 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative opioid usage
Secondary outcome measures
Mean pain score
Number of patients who report nausea or vomiting
Quality of recovery

Trial Design

2Treatment groups
Active Control
Group I: Group 1: IV acetaminophen and PO placeboActive Control1 Intervention
Group 1 will receive 1000 mg of IV acetaminophen approximately 30 minutes prior to skin closure and will receive oral placebo in the holding area prior to surgery
Group II: Group 2: PO acetaminophenActive Control1 Intervention
Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo.

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Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor
121 Previous Clinical Trials
21,496 Total Patients Enrolled

Media Library

Acetaminophen (Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT04574778 — Phase 3
Spinal Surgery Research Study Groups: Group 1: IV acetaminophen and PO placebo, Group 2: PO acetaminophen
Spinal Surgery Clinical Trial 2023: Acetaminophen Highlights & Side Effects. Trial Name: NCT04574778 — Phase 3
Acetaminophen (Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04574778 — Phase 3

Frequently Asked Questions

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

What are the indications for administering PO acetaminophen to Group 2 patients?

"Group 2: Acetaminophen administered orally is a viable therapeutic option for catarrh, rhinorrhea, musculoskeletal pain and muscle spasms."

Answered by AI

Has recruitment for this clinical trial commenced?

"Clinicaltrials.gov reports indicate that this clinical trial is presently recruiting patients, having been first posted on March 18th 2021 and last updated on August 15th 2023."

Answered by AI

Have other experiments employed oral acetaminophen in Group 2?

"Currently, there are 74 studies looking into Group 2: PO acetaminophen. Of those trials, 24 have advanced to Phase 3 and the bulk of them can be found in Saint Louis Missouri yet 703 other medical centres also run these experiments."

Answered by AI

To what extent is Group 2: PO acetaminophen hazardous to human health?

"Our team at Power evaluated the safety of Group 2: PO acetaminophen to be a 3 due to pre-existing clinical data suggesting efficacy and numerous rounds of testing validating its safety."

Answered by AI

How many patients are currently involved in this clinical investigation?

"Affirmative, information on clinicaltrials.gov suggests that this research is still actively seeking participants. Initially posted on March 18th 2021, the study was last modified on August 15th 2023 and requires 82 patients from a single centre to complete recruitment objectives."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy
2021. "Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04574778.
~11 spots leftby Oct 2024
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