Clinical trial NCT02487303: Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
Official title: Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Acetaminophen
Pain, Postoperative
Analgesia, Obstetrical
Cesarean Section
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative Postoperative Opiate Consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Time to First Opiate Rescue
timeFrame: 48 hours
measure: VAS (Visual Analog Scale)
timeFrame: 24 hours
measure: Time Discharge
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sylvia Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Alhashemi JA, Alotaibi QA, Mashaat MS, Kaid TM, Mujallid RH, Kaki AM. Intravenous acetaminophen vs oral ibuprofen in combination with morphine PCIA after Cesarean delivery. Can J Anaesth. 2006 Dec;53(12):1200-6. doi: 10.1007/BF03021581.
citation: Wong JY, Carvalho B, Riley ET. Intrathecal morphine 100 and 200 mug for post-cesarean delivery analgesia: a trade-off between analgesic efficacy and side effects. Int J Obstet Anesth. 2013 Jan;22(1):36-41. doi: 10.1016/j.ijoa.2012.09.006. Epub 2012 Nov 15.
citation: Singh SI, Rehou S, Marmai KL, Jones APM. The efficacy of 2 doses of epidural morphine for postcesarean delivery analgesia: a randomized noninferiority trial. Anesth Analg. 2013 Sep;117(3):677-685. doi: 10.1213/ANE.0b013e31829cfd21. Epub 2013 Aug 6.
citation: Beatty NC, Arendt KW, Niesen AD, Wittwer ED, Jacob AK. Analgesia after Cesarean delivery: a retrospective comparison of intrathecal hydromorphone and morphine. J Clin Anesth. 2013 Aug;25(5):379-383. doi: 10.1016/j.jclinane.2013.01.014. Epub 2013 Aug 17.
citation: Wilson SH, Wolf BJ, Robinson SM, Nelson C, Hebbar L. Intravenous vs Oral Acetaminophen for Analgesia After Cesarean Delivery: A Randomized Trial. Pain Med. 2019 Aug 1;20(8):1584-1591. doi: 10.1093/pm/pny253.