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Phase 4 N=132 Randomized Triple-blind Supportive Care

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief

Cesarean Section · Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT02046382 ↗
Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Total Oxycodone (mg) — 47.0; 65.0 mg

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
IV Acetaminophen (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
TriHealth Inc.
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Oxycodone (mg)		 47.0; 65.0 —
SECONDARY
Number of Participants With Narcotic Associated Side Effects		 17; 9 —
SECONDARY
Length of Stay		 78; 78 —

Summary

This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen among cesarean section patients. The study hopes to find out if patients who receive scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain scores and use less narcotic pain medication than patients who do not receive IV acetaminophen.

Eligibility Criteria

Inclusion Criteria

  • Age greater than or equal to 18 years
  • Scheduled cesarean section delivery
  • Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine Associates
  • Singleton pregnancy
  • Term delivery (greater than or equal to 37 weeks)
  • Spinal/epidural anesthesia with epidural analgesia (duramorph)
  • Use of pfannenstiel incision

Exclusion Criteria

  • Weight less than 50 kg
  • Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS)
  • Multiple gestation pregnancy
  • Cesarean section for pre-term delivery (less than 37 weeks)
  • Fetal anomalies
  • Inability to use epidural duramorph at time of procedure
  • General anesthesia used
  • Vertical skin incision
  • Opioid addiction
  • Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02046382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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