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Phase 4 N=52 Randomized Quadruple-blind Supportive Care

Dexamethasone for Post Cesarean Delivery Analgesia

Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT01868633 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Postoperative Analgesia — 11.8; 15 milligrams of morphine — p=0.32

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Dexamethasone (Drug); Placebo (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
University of Iowa
Primary completion
May 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Postoperative Analgesia		 11.8; 15 0.32
SECONDARY
Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery		 1; 1; 4; 4.5; 1; 2 —
SECONDARY
Quality of Recovery		 180; 177 —
SECONDARY
Incidence and Severity of Nausea and Pruritus		 6; 2.5; 5; 3; 0; 0 —

Summary

The purpose of this study is to assess the effectiveness intravenous (IV) dexamethasone when used as part of a multimodal regimen to manage post cesarean delivery pain. We hypothesize that a single dose of IV dexamethasone administered, as part of a multimodal analgesia after spinal anesthesia will significantly reduce post cesarean delivery opioid consumption and pain

Eligibility Criteria

Inclusion Criteria

  • English Speaking
  • Non-laboring women
  • Scheduled Elective Cesarean section under spinal anesthesia
  • American Society of Anesthesiologists I-II physical status

Exclusion Criteria

  • Contraindications to spinal anesthesia
  • allergy to study medication
  • patients with allergy to morphine
  • patients with uncontrolled hypertension
  • history of peptic ulcer disease
  • liver cirrhosis
  • diabetes mellitus
  • glaucoma
  • known IV drug abusers
  • patients with chronic pain or on long term opioids
  • patients administered steroids in the past week
  • women with fetuses having known congenital abnormalities
  • psychiatric illness such that they are unable to comprehend or participate in study questions
  • patients on antiviral medications or live virus vaccines would also be excluded.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01868633). 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.

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