Dexamethasone for Post-cesarean Delivery Pain
Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative; Postoperative Nausea and Vomiting
Intervention: Dexamethasone (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s): Terrence Allen, MD, Principal Investigator, Affiliation: Duke University
Overall contact: Jennifer Dominguez, MD, MHS, Phone: 919-970-8230, Email: jennifer.dominguez@dm.duke.edu
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.
Clinical Details
Official title: Dexamethasone as an Analgesic Adjunct for Post-cesarean Delivery Pain Relief
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Morphine consumption at 24 hours post-op
Secondary outcome: Pain scores between the groups at 2 hours.Time to first rescue analgesic request between the groups. Cumulative opioid consumption at 48 hours between the groups Pain scores between the groups at 24 hours. Pain scores between the groups at 48 hours.
Detailed description:
Steroids have been used to reduce inflammation and tissue damage in a variety of conditions,
have potent immunomodulatory effects, and are a mainstay in the treatment of acute allograft
rejection. Dexamethasone has been shown to be a safe and effective anti-emetic therapy for
patients undergoing cesarean section surgery with spinal anesthesia containing morphine.
However, recent evidence suggests that dexamethasone may also play a role in reducing
post-operative pain and opioid consumption. Early studies in patients undergoing dental
procedures showed that glucocorticoids were effective in reducing postoperative pain and
edema. Multiple recent studies have also investigated the potential analgesic benefit of a
single perioperative dose of dexamethasone, but the results have been inconsistent. The
effect of single-dose, intraoperative, intravenous dexamethasone therapy on post-operative
pain and opioid consumption has not yet been studied in patients undergoing cesarean
section.
Pain is a significant source of morbidity for many women following cesarean section, and has
serious consequences beyond the immediate post-operative period. Patients with
poorly-controlled pain may have difficulty with ambulation that can lead to atelectasis,
pneumonia, and venous thromboembolism.
Poor maternal pain control may also affect the infant by interfering with bonding and
breastfeeding. Reduction of post-operative opioid consumption is desirable because it may
also reduce the incidence of opioid-induced side effects such as sedation, constipation,
nausea, vomiting and pruritus. Some evidence suggests that the severity of post-operative
pain following cesarean section may predict progression to chronic pain, and postpartum
depression.
Although 10 to 18% of women who undergo cesarean section will experience chronic pain
following surgery, it is difficult to predict those patients who will experience this
complication. Recent investigations have shown that patient responses to standardized
painful stimuli prior to surgery help predict severity of post-operative pain and possibly
progression to chronic pain. This type of information could potentially help to tailor the
clinical management of patients at risk for severe and/or chronic post-operative pain to
improve outcomes for these patients. Landau and colleagues have described a simple and
minimally-invasive method of assessing response to noxious stimuli using a von-Frey filament
to obtain a mechanical temporal summation score.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Jennifer Dominguez, MD, MHS, Phone: 919-970-8230, Email: jennifer.dominguez@dm.duke.edu
Duke University Medical Center, Durham, North Carolina 27705, United States; Recruiting Jennifer Dominguez, MD, MHS, Sub-Investigator Terrence Allen, MD, Principal Investigator Maria Small, MD, MPH, Sub-Investigator Ashraf Habib, M.D., Sub-Investigator
Additional Information
Starting date: December 2012
Last updated: March 3, 2015
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