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Completed

NCT Number: NCT01812057

Dexamethasone for Post-cesarean Delivery Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 8 mg IV (as a one time dose)

Placebo

Drug

Sodium Chloride 0.9% -5 ml

Other names: Sodium Chloride 0.9%

Primary outcomes

  1. Morphine Consumption at 24 Hours Post-op

    Time frame: 24 hours from admission to Postanesthesia care unit (PACU)

    The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine

Secondary outcomes

  1. Pain Scores Between the Groups at 2 Hours.

    Time frame: 2 hours from admission to postanesthesia care unit (PACU)

    Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.

  2. Time to Administration of First Rescue Analgesic Request Between the Groups.

    Time frame: PACU admission to discharge from PACU an average of 2 hours

    Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain

  3. Cumulative Opioid Consumption at 48 Hours Between the Groups

    Time frame: Admission to PACU through 48 hours

    The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine

  4. Pain Scores Between the Groups at 24 Hours.

    Time frame: 24 hours from PACU admission

    Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.

  5. Pain Scores Between the Groups at 48 Hours.

    Time frame: 48 hours from PACU Admission

    Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.

  6. Cumulative Opioid Consumption at 24 Hours Between MTS Groups

    Time frame: 24 hours from admission to Postanesthesia care unit (PACU)

    Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.

  7. Incidence of Chronic Persistent Pain at 8 Weeks

    Time frame: 8 weeks from the day of surgery

    Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery

  8. Incidence of Chronic Persistent Pain at 6 Months

    Time frame: 6 months from the day of surgery

    Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery

  9. Pain Scores Between MTS Groups

    Time frame: 24 hours after PACU admission

    Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.

  10. Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.

    Time frame: From spinal anesthesia placement to end of surgery, approximately 70 minutes

    Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic.

  11. Incidence of Intraoperative Pruritus

    Time frame: From spinal anesthesia placement to end of surgery, approximately 70 minutes

    pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus

  12. Incidence of Postoperative Pruritus

    Time frame: 48 hours from admission to PACU

    Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated.

    If median score >0 then patient experienced postoperative pruritus.

  13. Need for Intraoperative Analgesic Supplementation

    Time frame: From spinal anesthesia placement to end of surgery, approximately 70 minutes

    Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain

  14. Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics

    Time frame: 2, 24 and 48 hours from PACU admission

    Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from >0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV.

    Patients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic

  15. Incidence of Wound Complications

    Time frame: 24 hours from PACU admission

    Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery

  16. Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)

    Time frame: Intraoperatively

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 15, 2013
Registry last updated
Jul 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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