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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cesarean Section Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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IV Acetaminophen

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.

Group Type EXPERIMENTAL

IV Acetaminophen

Intervention Type DRUG

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.

Normal Saline

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Interventions

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IV Acetaminophen

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.

Intervention Type DRUG

Placebo

100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Intervention Type DRUG

Other Intervention Names

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Ofirmev Normal Saline

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No