Phase 4
Completed N=66
IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
Post-operative Pain
Source: ClinicalTrials.gov NCT02069184 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Opioid Requirements in Cesarean Section (C-section) Patient Population — 44; 48; 58; 57 mg
◆ Published Evidence
Emerging
6citations · ~2 / year
The analgesic efficacy of IV acetaminophen for acute postoperative pain in C-section patients: a randomized, double-blind, placebo-controlled study.
Summary
Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.
Linked Publications
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The analgesic efficacy of IV acetaminophen for acute postoperative pain in C-section patients: a randomized, double-blind, placebo-controlled study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Requirements in Cesarean Section (C-section) Patient Population |
44; 48; 58; 57 | — |
| SECONDARY Visual Analog Score (VAS) Pain Score |
2.2; 1.4; 3.4; 3.6; 1.2; 2.3 | — |
| SECONDARY Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section |
95; 95 | — |
| SECONDARY "Percentage of Patients With Adverse Events After the Surgery |
22; 27; 21; 27; 57; 63 | — |
| SECONDARY Number of Participants Using Patient-controlled Analgesia (PCA) Attempts |
— | — |
| SECONDARY Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge |
0; 0 | — |
| SECONDARY Pain Medication Usage ( NSAIDS) |
27; 30.3 | — |
Eligibility Criteria
Inclusion Criteria
- Elective full term CS patients
- Age 18 and above
- ASA I-III
Exclusion Criteria
- Allergic reaction to IV acetaminophen
- Not able to understand and sign the research consent
- Pregnancy induced hypertension or pre-eclampsia patients
- Planned intensive care admission patients
- Patients with severe hepatic impairment or active liver diseases (Two fold increase in any of the liver enzymes)
- Patients with serum creatinine>2mg/dl
- For nursing mothers, any evidence of hepatic dysfunction of the new born
Data sourced from ClinicalTrials.gov (NCT02069184) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.