Clinical trial NCT01812057: Dexamethasone for Post-cesarean Delivery Pain
Official title: Dexamethasone as an Analgesic Adjunct for Post-cesarean Delivery Pain Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Postoperative Nausea and Vomiting
Keywords: Anesthesia
Cesarean Section
Pain, Postoperative
Postoperative Nausea and Vomiting
Dexamethasone
Injections, Spinal
morphine
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Morphine Consumption at 24 Hours Post-op
timeFrame: 24 hours from admission to Postanesthesia care unit (PACU)
Secondary outcomes:
measure: Pain Scores Between the Groups at 2 Hours.
timeFrame: 2 hours from admission to postanesthesia care unit (PACU)
measure: Time to Administration of First Rescue Analgesic Request Between the Groups.
timeFrame: PACU admission to discharge from PACU an average of 2 hours
measure: Cumulative Opioid Consumption at 48 Hours Between the Groups
timeFrame: Admission to PACU through 48 hours
measure: Pain Scores Between the Groups at 24 Hours.
timeFrame: 24 hours from PACU admission
measure: Pain Scores Between the Groups at 48 Hours.
timeFrame: 48 hours from PACU Admission
measure: Cumulative Opioid Consumption at 24 Hours Between MTS Groups
timeFrame: 24 hours from admission to Postanesthesia care unit (PACU)
measure: Incidence of Chronic Persistent Pain at 8 Weeks
timeFrame: 8 weeks from the day of surgery
measure: Incidence of Chronic Persistent Pain at 6 Months
timeFrame: 6 months from the day of surgery
measure: Pain Scores Between MTS Groups
timeFrame: 24 hours after PACU admission
measure: Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.
timeFrame: From spinal anesthesia placement to end of surgery, approximately 70 minutes
measure: Incidence of Intraoperative Pruritus
timeFrame: From spinal anesthesia placement to end of surgery, approximately 70 minutes
measure: Incidence of Postoperative Pruritus
timeFrame: 48 hours from admission to PACU
measure: Need for Intraoperative Analgesic Supplementation
timeFrame: From spinal anesthesia placement to end of surgery, approximately 70 minutes
measure: Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics
timeFrame: 2, 24 and 48 hours from PACU admission
measure: Incidence of Wound Complications
timeFrame: 24 hours from PACU admission
measure: Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Terrence Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.