A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section

Main Line Health

Status and phase: Unknown; Phase 4

Conditions: Postoperative Pain; Cesarean Section; Acetaminophen

Treatments: Drug: Placebos; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT04290208

F/N-R19-3892BLP

Details and patient eligibility

About

This randomized controlled study will compare narcotic consumption between two groups: patients that receive a perioperative dose of IV acetaminophen versus patients that receive a perioperative dose of oral liquid acetaminophen for scheduled cesarean section.

Full description

"Enhanced recovery" is an alternate management protocol described by a multi-modal, evidence based approach to peri-operative care, with the goal of accelerating recovery and return to normal activity after surgery. Results have shown stable pain control with a decrease in narcotic consumption, a quicker return of bowel function, and decreased length of hospital stay and cost with no change in level of patient satisfaction, morbidity, or readmission rate. An aspect of some alternate management protocols is the administration of acetaminophen.

The concentration of acetaminophen in cerebrospinal fluid (CSF) is directly proportional to the analgesic activity of acetaminophen. Acetaminophen relies on a high concentration gradient from the plasma to the CSF in order to passively diffuse into the central nervous system (CNS), its principal site of action. A 2012 study, comparing plasma and CSF pharmacokinetics of intravenous (IV), oral (PO), or rectal (PR) acetaminophen, concluded that IV administration of acetaminophen results in higher plasma and CSF concentration values. Therefore, IV acetaminophen produces better CNS penetration compared to PO or PR methods.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women age 18 or older
• Scheduled to undergo a cesarean section

Exclusion criteria

• Existing diagnosis of chronic pain
• Need to undergo a vertical skin incision
• Aspartate Aminotransferase (AST) > 50, alanine aminotransferase (ALT) > 70
• Platelets below 80,000 on admission
• Need to undergo general anesthesia
• Tubal ligation at time of Cesarean section
• Prior or known allergy to any of the medications being utilized in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups

Intravenous Administration of Acetaminophen

Active Comparator group

Description:

A single peri-operative dose of acetaminophen 1000 mg IV over 15 minutes after skin is closed.

Treatment:

Drug: Placebos

Drug: Acetaminophen

Drug: Acetaminophen

Drug: Placebos

Per Oral Administration of Acetaminophen

Active Comparator group

Description:

A pre-operative liquid dose of acetaminophen 1000mg orally in the on-call to Operative Room.

Treatment:

Drug: Placebos

Drug: Acetaminophen

Drug: Acetaminophen

Drug: Placebos