Pain, PostoperativePhase 4NCT01812057
Dexamethasone for Post-cesarean Delivery Pain
A Phase 4 study testing Dexamethasone in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative, Postoperative Nausea and Vomiting
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 21 Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Dexamethasone as an Analgesic Adjunct for Post-cesarean Delivery Pain Relief
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.
Read the 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.
- Being tested
- Dexamethasone, Placebo
- Keywords
- Anesthesia, Cesarean Section, Pain, Postoperative, Postoperative Nausea and Vomiting, Dexamethasone, Injections, Spinal, morphine
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone 8 mg IV (as a one time dose)
PlaceboDrug
Also called Sodium Chloride 0.9%
Sodium Chloride 0.9% -5 ml
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone 8 mg IV given intraoperatively as a one-time dose. Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours from admission to Postanesthesia care unit (PACU)
Secondary outcomes (16)
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.
Measured: 2 hours from admission to postanesthesia care unit (PACU)
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
Measured: PACU admission to discharge from PACU an average of 2 hours
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
Measured: Admission to PACU through 48 hours
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.
Measured: 24 hours from PACU admission
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.
Measured: 48 hours from PACU Admission
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.
Measured: 24 hours from admission to Postanesthesia care unit (PACU)
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
Measured: 8 weeks from the day of 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
Measured: 6 months from the day of 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.
Measured: 24 hours after PACU admission
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.
Measured: From spinal anesthesia placement to end of surgery, approximately 70 minutes
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
Measured: From spinal anesthesia placement to end of surgery, approximately 70 minutes
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.
Measured: 48 hours from admission to PACU
Need for Intraoperative Analgesic Supplementation
Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain
Measured: From spinal anesthesia placement to end of surgery, approximately 70 minutes
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
Measured: 2, 24 and 48 hours from PACU admission
Incidence of Wound Complications
Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery
Measured: 24 hours from PACU admission
Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startDec 2012
- Primary completion27 May 2016
- Study completion21 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terrence Allen, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812057
- Sponsor's protocol ID
- Pro00041334
- Status last verified
- Jun 2017
- First submitted
- 13 Mar 2013
- Last updated
- 25 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 34002866
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone as an Analgesic Adjunct for Post-cesarean Delivery Pain Relief
- ClinicalTrials.gov ID
- NCT01812057
- Acronym / sponsor ID
- Pro00041334
- Keywords
- Anesthesia, Cesarean Section, Pain, Postoperative, Postoperative Nausea and Vomiting, Dexamethasone, Injections, Spinal, morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- 27 May 2016 (actual)
- Study completion
- 21 Sep 2016 (actual)
- First posted
- 15 Mar 2013 (estimated)
- Results
- Posted 25 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneDexamethasone 8 mg IV given intraoperatively as a one-time dose. |
| Placebo | Placebo comparator | Drug: PlaceboSodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone 8 mg IV (as a one time dose) | Drug | Dexamethasone |
| PlaceboAlso: Sodium Chloride 0.9%Sodium Chloride 0.9% -5 ml | Drug | Placebo |
Primary outcome
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
16 secondary outcomes
Pain Scores Between the Groups at 2 Hours.
Time frame: 2 hours from admission to postanesthesia care unit (PACU)
Time to Administration of First Rescue Analgesic Request Between the Groups.
Time frame: PACU admission to discharge from PACU an average of 2 hours
Cumulative Opioid Consumption at 48 Hours Between the Groups
Time frame: Admission to PACU through 48 hours
Pain Scores Between the Groups at 24 Hours.
Time frame: 24 hours from PACU admission
Pain Scores Between the Groups at 48 Hours.
Time frame: 48 hours from PACU Admission
Cumulative Opioid Consumption at 24 Hours Between MTS Groups
Time frame: 24 hours from admission to Postanesthesia care unit (PACU)
Incidence of Chronic Persistent Pain at 8 Weeks
Time frame: 8 weeks from the day of surgery
Incidence of Chronic Persistent Pain at 6 Months
Time frame: 6 months from the day of surgery
Pain Scores Between MTS Groups
Time frame: 24 hours after PACU admission
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 Pruritus
Time frame: From spinal anesthesia placement to end of surgery, approximately 70 minutes
Incidence of Postoperative Pruritus
Time frame: 48 hours from admission to PACU
Need for Intraoperative Analgesic Supplementation
Time frame: From spinal anesthesia placement to end of surgery, approximately 70 minutes
Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics
Time frame: 2, 24 and 48 hours from PACU admission
Incidence of Wound Complications
Time frame: 24 hours from PACU admission
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34002866Griffiths 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrence Allen, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Consumption at 24 Hours Post-op (time frame: 24 hours from admission to Postanesthesia care unit (PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01812057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.