Phase 4 N=49 Randomized Quadruple-blind Prevention

Dexamethasone for Post-cesarean Delivery Pain

Pain, Postoperative · Postoperative Nausea and Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT01812057 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2017

Primary outcome: Primary: Morphine Consumption at 24 Hours Post-op — 15; 13.75 milligram — p=0.740

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dexamethasone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Duke University
Primary completion: May 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Morphine Consumption at 24 Hours Post-op	15; 13.75	0.740
SECONDARY Pain Scores Between the Groups at 2 Hours.	2; 3.5; 5; 5	0.171
SECONDARY Time to Administration of First Rescue Analgesic Request Between the Groups.	52.5; 70	0.1965
SECONDARY Cumulative Opioid Consumption at 48 Hours Between the Groups	20; 22.5	0.709
SECONDARY Pain Scores Between the Groups at 24 Hours.	2; 2.5; 5; 5	0.267
SECONDARY Pain Scores Between the Groups at 48 Hours.	2.0; 2.0; 4.0; 5.0	0.491
SECONDARY Cumulative Opioid Consumption at 24 Hours Between MTS Groups	17.5; 15	0.355
SECONDARY Incidence of Chronic Persistent Pain at 8 Weeks	2; 6	0.420
SECONDARY Incidence of Chronic Persistent Pain at 6 Months	3; 1	0.322
SECONDARY Pain Scores Between MTS Groups	2.0; 2.0; 5.0; 4.0	0.805
SECONDARY Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.	5; 2; 10; 9; 4; 5	0.245
SECONDARY Incidence of Intraoperative Pruritus	—	—
SECONDARY Incidence of Postoperative Pruritus	16; 17	0.924
SECONDARY Need for Intraoperative Analgesic Supplementation	4; 3	0.700
SECONDARY Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics	9; 13; 10; 18; 1; 2	0.302
SECONDARY Incidence of Wound Complications	0; 0	—
SECONDARY Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)	—	—

Summary

The purpose of this study is to compare post-cesarean section consumption of pain medication between two groups of patients undergoing scheduled cesarean section at term gestation who receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo at 24 hours after surgery. The hypothesis is that a single perioperative dose of dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in women having cesarean delivery under spinal anesthesia.

Eligibility Criteria

Inclusion Criteria

American Society of Anesthesiology (ASA) class 1, 2 and 3
Gestational age > 37 weeks
scheduled for elective cesarean delivery
spinal or combined spinal epidural anesthesia
18 years or older
speak English

Exclusion Criteria

BMI > 45 kg/m2
Diabetes Mellitus (Type 1, 2 and gestational)
mild or severe preeclampsia
history of intravenous drug or opioid abuse
previous history of chronic pain syndrome
history of opioid use in the past week
receipt of an antiemetic within 24 h prior to surgery
Non-English speaking

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01812057). 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.