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

TriHealth

Status and phase: Completed; Phase 4

Conditions: Cesarean Section; Pain, Postoperative

Treatments: Drug: Placebo; Drug: IV Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02046382

13068

Details and patient eligibility

About

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.

Full description

See Brief Summary

Enrollment: 132 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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132 participants in 2 patient groups, including a placebo group

IV Acetaminophen

Experimental group

Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Treatment:

Drug: IV Acetaminophen

Normal Saline

Placebo Comparator group

Description:

Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Treatment:

Drug: Placebo