search
Back to results

Dexamethasone for Post-cesarean Delivery Pain

Primary Purpose

Pain, Postoperative, Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Anesthesia, Cesarean Section, Pain, Postoperative, Postoperative Nausea and Vomiting, Dexamethasone, Injections, Spinal, morphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

Dexamethasone 8 mg IV given intraoperatively as a one-time dose.

Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.

Outcomes

Primary Outcome Measures

Morphine Consumption at 24 Hours Post-op
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 Outcome Measures

Pain Scores Between the Groups at 2 Hours.
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.
Time to Administration of First Rescue Analgesic Request Between the Groups.
Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain
Cumulative Opioid Consumption at 48 Hours Between the Groups
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
Pain Scores Between the Groups at 24 Hours.
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.
Pain Scores Between the Groups at 48 Hours.
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.
Cumulative Opioid Consumption at 24 Hours Between MTS Groups
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.
Incidence of Chronic Persistent Pain at 8 Weeks
Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery
Incidence of Chronic Persistent Pain at 6 Months
Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery
Pain Scores Between MTS Groups
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.
Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.
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.
Incidence of Intraoperative Pruritus
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
Incidence of Postoperative Pruritus
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.
Need for Intraoperative Analgesic Supplementation
Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain
Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics
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
Incidence of Wound Complications
Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery
Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)

Full Information

First Posted
March 13, 2013
Last Updated
June 26, 2017
Sponsor
Duke University
search

1. Study Identification

Unique Protocol Identification Number
NCT01812057
Brief Title
Dexamethasone for Post-cesarean Delivery Pain
Official Title
Dexamethasone as an Analgesic Adjunct for Post-cesarean Delivery Pain Relief
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
May 27, 2016 (Actual)
Study Completion Date
September 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Postoperative Nausea and Vomiting
Keywords
Anesthesia, Cesarean Section, Pain, Postoperative, Postoperative Nausea and Vomiting, Dexamethasone, Injections, Spinal, morphine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 8 mg IV (as a one time dose)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sodium Chloride 0.9%
Intervention Description
Sodium Chloride 0.9% -5 ml
Primary Outcome Measure Information:
Title
Morphine Consumption at 24 Hours Post-op
Description
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
Time Frame
24 hours from admission to Postanesthesia care unit (PACU)
Secondary Outcome Measure Information:
Title
Pain Scores Between the Groups at 2 Hours.
Description
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.
Time Frame
2 hours from admission to postanesthesia care unit (PACU)
Title
Time to Administration of First Rescue Analgesic Request Between the Groups.
Description
Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain
Time Frame
PACU admission to discharge from PACU an average of 2 hours
Title
Cumulative Opioid Consumption at 48 Hours Between the Groups
Description
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
Time Frame
Admission to PACU through 48 hours
Title
Pain Scores Between the Groups at 24 Hours.
Description
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.
Time Frame
24 hours from PACU admission
Title
Pain Scores Between the Groups at 48 Hours.
Description
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.
Time Frame
48 hours from PACU Admission
Title
Cumulative Opioid Consumption at 24 Hours Between MTS Groups
Description
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.
Time Frame
24 hours from admission to Postanesthesia care unit (PACU)
Title
Incidence of Chronic Persistent Pain at 8 Weeks
Description
Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery
Time Frame
8 weeks from the day of surgery
Title
Incidence of Chronic Persistent Pain at 6 Months
Description
Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery
Time Frame
6 months from the day of surgery
Title
Pain Scores Between MTS Groups
Description
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.
Time Frame
24 hours after PACU admission
Title
Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.
Description
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.
Time Frame
From spinal anesthesia placement to end of surgery, approximately 70 minutes
Title
Incidence of Intraoperative Pruritus
Description
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
Time Frame
From spinal anesthesia placement to end of surgery, approximately 70 minutes
Title
Incidence of Postoperative Pruritus
Description
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.
Time Frame
48 hours from admission to PACU
Title
Need for Intraoperative Analgesic Supplementation
Description
Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain
Time Frame
From spinal anesthesia placement to end of surgery, approximately 70 minutes
Title
Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics
Description
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
Time Frame
2, 24 and 48 hours from PACU admission
Title
Incidence of Wound Complications
Description
Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery
Time Frame
24 hours from PACU admission
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrence Allen, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34002866
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.
Results Reference
derived

Learn more about this trial

Dexamethasone for Post-cesarean Delivery Pain

We'll reach out to this number within 24 hrs