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Completed

NCT Number: NCT02487303

Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.

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Key information

Conditions

Pain, Postoperative Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three by a computer generated list.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parturients 18 years
  • Elective Cesarean delivery
  • Spinal anesthesia
  • Able to consent to the study and participate in the follow-up.

Exclusion criteria

  • Weight under 50 kgs
  • Allergy to acetaminophen
  • General anesthesia
  • Urgent or emergent cases
  • Bleeding diathesis or other coagulopathy
  • G6PD deficiency
  • Liver disease
  • Substance abuse or dependence
  • HELLP syndrome
  • Thrombocytopenia or platelet dysfunction
  • History or active gastrointestinal bleeding
  • Acute kidney injury or chronic renal insufficiency
  • Contraindication/refusal to spinal anesthesia
  • Chronic pain
  • Chronic narcotic use
  • Illicit drug use
  • Allergy to any study related medications.

Treatment and study plan

Acetaminophen Intravenous

Drug

IV 1 gram f3 doses over 24 hours

Other names: Tylenol

Acetaminophen Oral

Drug

Oral 1 gram 3 doses over 24 hours

Other names: Tylenol

Primary outcomes

  1. Cumulative Postoperative Opiate Consumption

    Time frame: 24 hours

    Cumulative opiate consumption (IV morphine equivalents)

Secondary outcomes

  1. Time to First Opiate Rescue

    Time frame: 48 hours

    Time to first opiate pain medicine requested by patient

  2. VAS (Visual Analog Scale)

    Time frame: 24 hours

    Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) .

  3. Time Discharge

    Time frame: 24 hours postoperative

    Time patient meets discharge criteria will be recorded

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2015
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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