Dexamethasone for Post-cesarean Delivery Pain

Pain, Postoperative Clinical Trial

Official title:

Dexamethasone as an Analgesic Adjunct for Post-cesarean Delivery Pain Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812057
• Other study ID #: Pro00041334
• Status: Completed
• Phase: Phase 4
• First received: March 13, 2013
• Last updated: September 12, 2016
• Start date: December 2012
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Dexamethasone
Dexamethasone 8 mg IV (as a one time dose)
• Placebo
Sodium Chloride 0.9% -5 ml

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption at 24 hours post-op	The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups.	24 hours	No
Secondary	Pain scores between the groups at 2 hours.		2 hours	No
Secondary	Time to first rescue analgesic request between the groups.		24 hours	No
Secondary	Cumulative opioid consumption at 48 hours between the groups		48 hours	No
Secondary	Pain scores between the groups at 24 hours.		24 hours	No
Secondary	Pain scores between the groups at 48 hours.		48 hours	No