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Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen Intravenous
Acetaminophen Oral
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Acetaminophen, Pain, Postoperative, Analgesia, Obstetrical, Cesarean Section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Acetaminophen Intravenous

Acetaminophen Oral

No acetaminophen

Arm Description

(group 1) 1 gram IV acetaminophen every 8 hours for three doses

(group 2) 1 gram oral acetaminophen every 8 hours for three doses

(group 3) no acetaminophen

Outcomes

Primary Outcome Measures

Cumulative Postoperative Opiate Consumption
Cumulative opiate consumption (IV morphine equivalents)

Secondary Outcome Measures

Time to First Opiate Rescue
Time to first opiate pain medicine requested by patient
VAS (Visual Analog Scale)
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]) .
Time Discharge
Time patient meets discharge criteria will be recorded

Full Information

First Posted
June 25, 2015
Last Updated
November 5, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02487303
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 17, 2015 (Actual)
Primary Completion Date
July 27, 2017 (Actual)
Study Completion Date
July 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Acetaminophen, Pain, Postoperative, Analgesia, Obstetrical, Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen Intravenous
Arm Type
Active Comparator
Arm Description
(group 1) 1 gram IV acetaminophen every 8 hours for three doses
Arm Title
Acetaminophen Oral
Arm Type
Active Comparator
Arm Description
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
Arm Title
No acetaminophen
Arm Type
No Intervention
Arm Description
(group 3) no acetaminophen
Intervention Type
Drug
Intervention Name(s)
Acetaminophen Intravenous
Other Intervention Name(s)
Tylenol
Intervention Description
IV 1 gram f3 doses over 24 hours
Intervention Type
Drug
Intervention Name(s)
Acetaminophen Oral
Other Intervention Name(s)
Tylenol
Intervention Description
Oral 1 gram 3 doses over 24 hours
Primary Outcome Measure Information:
Title
Cumulative Postoperative Opiate Consumption
Description
Cumulative opiate consumption (IV morphine equivalents)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time to First Opiate Rescue
Description
Time to first opiate pain medicine requested by patient
Time Frame
48 hours
Title
VAS (Visual Analog Scale)
Description
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]) .
Time Frame
24 hours
Title
Time Discharge
Description
Time patient meets discharge criteria will be recorded
Time Frame
24 hours postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia Wilson, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21114616
Citation
Macario A, Royal MA. A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain Pract. 2011 May-Jun;11(3):290-6. doi: 10.1111/j.1533-2500.2010.00426.x. Epub 2010 Nov 28.
Results Reference
result
PubMed Identifier
21627768
Citation
Smith HS. Perioperative intravenous acetaminophen and NSAIDs. Pain Med. 2011 Jun;12(6):961-81. doi: 10.1111/j.1526-4637.2011.01141.x. Epub 2011 May 31.
Results Reference
result
PubMed Identifier
21353105
Citation
Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011.
Results Reference
result
PubMed Identifier
22524979
Citation
Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.
Results Reference
result
PubMed Identifier
23220855
Citation
Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6.
Results Reference
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PubMed Identifier
17142654
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.
Results Reference
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PubMed Identifier
23159009
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.
Results Reference
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PubMed Identifier
23921652
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.
Results Reference
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PubMed Identifier
23965210
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.
Results Reference
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PubMed Identifier
30561704
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.
Results Reference
derived

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Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

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