PregnancyNCT07257406
Dexamethasone for Post-operative Pain After Cesarean Delivery Under Neuraxial Anesthesia.
A study testing Dexamethasone (IV) in people with Pregnancy and Cesarean Delivery, run by Valerie Zaphiratos at 1 site in Canada.
Trial summary
After surgery pain in women who have had a cesarean delivery is a determining factor in the quality and duration of their hospital stay. Insufficient pain relief can lead to longer hospitalization and long term pain, which can result in long term use of pain medication. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Cesarean Delivery, Dexamethasone
- What is being tested?
- Dexamethasone (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteCanada
- Study dates
- 13 Sep 2018to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years
- Cesarean delivery
- Planned spinal or combined neuraxial anesthesia
- Presence of an investigator in the delivery room
- Pregnancy > 34 weeks gestation
Who cannot join
- Cesarean delivery under general anesthesia
- Inability to understand French or English
- Allergy or hypersensitivity to dexamethasone
- Allergy to hydromorphone
- Allergy to NSAIDs
- Acute kidney injury or chronic kidney failure
Show all 17Show fewer
- Preeclampsia
- Extremely urgent cesarean section
- Urgent cesarean section with non-reassuring fetal monitoring
- Known maternal heart disease
- High-grade placental abnormality
- Diabetes (pregnancy or pre-existing)
- Systemic infection, sepsis, fever
- Regular use of dexamethasone in the last year
- Weight greater than 120 kg and less than 70 kg
- Height less than 150 cm
- Chronic pain and/or chronic use of opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Intravenous Dexamethasone for Post-operative Pain After Cesarean Delivery Under Neuraxial Anesthesia.
After surgery pain in women who have had a cesarean delivery is a determining factor in the quality and duration of their hospital stay. Insufficient pain relief can lead to longer hospitalization and long term pain, which can result in long term use of pain medication. A classic method to alleviate pain after cesarean delivery is by injecting morphine into the spinal fluid, in the women's back, in addition to prescribing morphine by mouth as needed after the surgery. However, the negative effects associated with morphine and morphine-like drugs, limit the doses used, their pain relief capacity, and can negatively affect the after surgical experience of women. An approach which uses pain relief that acts on different pain pathways to treat after surgery pain helps limit the negative effects of different drugs. The potential benefit of dexamethasone as pain relief in women who have had a cesarean delivery is all the more interesting because of its minimal negative effects compared to morphine-like drugs. Its low cost, its effectiveness to prevent nausea, and its impact on the general condition of patients make dexamethasone even more attractive.
Read the detailed description
Postoperative pain in patients who have undergone a cesarean delivery is a determining factor in the quality and duration of their hospital stay. Suboptimal analgesia can lead to prolonged hospitalization and chronic pain, which can result in chronic use of pain medication. Treatment of post-operative pain after cesarean delivery uses intrathecal morphine, and the use of opioids as needed post-operatively. However, the side effects associated with opioids limit the doses used, their analgesic efficacy, and adversely affect the postoperative experience of patients. The multimodal approach to postoperative pain allows for analgesia that acts on different pain mechanisms while limiting the adverse effects of different drugs. The potential benefits of dexamethasone as a co-analgesic in women who have had a cesarean section are all the more interesting because of its minimal adverse effects compared to opioids. Its low cost, its effectiveness as antiemetic prophylaxis, and its impact on the general condition of patients make dexamethasone even more attractive.
In this randomised controlled trial, 100 patients are to be recruited and randomised to one of two groups. Both groups will receive standard treatment. In addition to standard treatment, the first group will receive dexamethasone 8 mg IV after umbilical cord clamping and the other group will receive a placebo.
The patients will be followed for 24 hours post-operatively. Their pain levels at rest and during movement will be recorded on an 11 point pain scale. The dose of hydromorphone used in the first 24 hours will be recorded. The patients are also asked to complete the QOR-40 questionnaire, which aims to assess the quality of their postoperative recovery. The primary outcome is the pain on an 11 point scale at the first rise 6 hours post-operatively.
The investigators hypothesize that dexamethasone will improve pain scores and diminish opioid use in the first 24 hours post-operatively.
- Conditions
- Pregnancy, Cesarean Delivery, Dexamethasone
- Being tested
- Dexamethasone (IV), Placebo
- Keywords
- pregnancy, dexamethasone, cesarean, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (IV)Drug
Dexamethasone 8 mg IV will be given 5 minutes after cord clamping in the interventional arm.
PlaceboDrug
This arm will receive 2 ml of saline 5 min after cord clamping.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | Participants who receive dexamethasone 8 mg IV (2 ml) 5 min after cord clamping. Receives: Drug: Dexamethasone (IV) |
| Placebo | Placebo comparator | Participants who receive 0.9% saline IV (2 ml) 5 min after cord clamping. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Pain Score (VAS) 6 hours post-operatively at first rise
Visual Analog Pain Score (VAS), from 0 to 10, when patients first stand out of bed 6 hours post-operatively. A score of 0 on 10 being no pain, and a score of 10 on 10 being the worst pain imaginable.
Measured: 6 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start13 Sep 2018
- Primary completion8 Jun 2021
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerie Zaphiratos
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Sponsor-investigator, Valerie Zaphiratos, St. Justine's Hospital
- Investigators
- Valerie Zaphiratos, MD MSc FRCPC, Principal investigator, CHU Sainte-Justine, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257406
- Sponsor's protocol ID
- 2019-1840
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If a researcher needs IPD for a meta-analysis for instance, they can contact me.
Publications
Mohtadi A, Nesioonpour S, Salari A, Akhondzadeh R, Masood Rad B, Aslani SM. The effect of single-dose administration of dexamethasone on postoperative pain in patients undergoing laparoscopic cholecystectomy. Anesth Pain Med. 2014 Aug 13;4(3):e17872. doi: 10.5812/aapm.17872. eCollection 2014 Aug.
PubMed 25237639Shahraki AD, Feizi A, Jabalameli M, Nouri S. The effect of intravenous Dexamethasone on post-cesarean section pain and vital signs: A double-blind randomized clinical trial. J Res Pharm Pract. 2013 Jul;2(3):99-104. doi: 10.4103/2279-042X.122370.
PubMed 24991614Cardoso MM, Leite AO, Santos EA, Gozzani JL, Mathias LA. Effect of dexamethasone on prevention of postoperative nausea, vomiting and pain after caesarean section: a randomised, placebo-controlled, double-blind trial. Eur J Anaesthesiol. 2013 Mar;30(3):102-5. doi: 10.1097/EJA.0b013e328356676b.
PubMed 23022704
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intravenous Dexamethasone for Post-operative Pain After Cesarean Delivery Under Neuraxial Anesthesia.
- ClinicalTrials.gov ID
- NCT07257406
- Acronym / sponsor ID
- 2019-1840
- Conditions
- Pregnancy, Cesarean Delivery, Dexamethasone
- Keywords
- pregnancy, dexamethasone, cesarean, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Valerie ZaphiratosUniversity, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 13 Sep 2018 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After surgery pain in women who have had a cesarean delivery is a determining factor in the quality and duration of their hospital stay. Insufficient pain relief can lead to longer hospitalization and long term pain, which can result in long term use of pain medication. A classic method to alleviate pain after cesarean delivery is by injecting morphine into the spinal fluid, in the women's back, in addition to prescribing morphine by mouth as needed after the surgery. However, the negative effects associated with morphine and morphine-like drugs, limit the doses used, their pain relief capacity, and can negatively affect the after surgical experience of women. An approach which uses pain relief that acts on different pain pathways to treat after surgery pain helps limit the negative effects of different drugs. The potential benefit of dexamethasone as pain relief in women who have had a cesarean delivery is all the more interesting because of its minimal negative effects compared to morphine-like drugs. Its low cost, its effectiveness to prevent nausea, and its impact on the general condition of patients make dexamethasone even more attractive.
Detailed description
Postoperative pain in patients who have undergone a cesarean delivery is a determining factor in the quality and duration of their hospital stay. Suboptimal analgesia can lead to prolonged hospitalization and chronic pain, which can result in chronic use of pain medication. Treatment of post-operative pain after cesarean delivery uses intrathecal morphine, and the use of opioids as needed post-operatively. However, the side effects associated with opioids limit the doses used, their analgesic efficacy, and adversely affect the postoperative experience of patients. The multimodal approach to postoperative pain allows for analgesia that acts on different pain mechanisms while limiting the adverse effects of different drugs. The potential benefits of dexamethasone as a co-analgesic in women who have had a cesarean section are all the more interesting because of its minimal adverse effects compared to opioids. Its low cost, its effectiveness as antiemetic prophylaxis, and its impact on the general condition of patients make dexamethasone even more attractive.
In this randomised controlled trial, 100 patients are to be recruited and randomised to one of two groups. Both groups will receive standard treatment. In addition to standard treatment, the first group will receive dexamethasone 8 mg IV after umbilical cord clamping and the other group will receive a placebo.
The patients will be followed for 24 hours post-operatively. Their pain levels at rest and during movement will be recorded on an 11 point pain scale. The dose of hydromorphone used in the first 24 hours will be recorded. The patients are also asked to complete the QOR-40 questionnaire, which aims to assess the quality of their postoperative recovery. The primary outcome is the pain on an 11 point scale at the first rise 6 hours post-operatively.
The investigators hypothesize that dexamethasone will improve pain scores and diminish opioid use in the first 24 hours post-operatively.
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 | Active comparator | Drug: Dexamethasone (IV)Participants who receive dexamethasone 8 mg IV (2 ml) 5 min after cord clamping. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants who receive 0.9% saline IV (2 ml) 5 min after cord clamping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Cesarean delivery
- Planned spinal or combined neuraxial anesthesia
- Presence of an investigator in the delivery room
- Pregnancy > 34 weeks gestation
Key exclusion criteria (17 listed)
- Cesarean delivery under general anesthesia
- Inability to understand French or English
- Allergy or hypersensitivity to dexamethasone
- Allergy to hydromorphone
- Allergy to NSAIDs
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 |
|---|---|---|
| Dexamethasone (IV)Dexamethasone 8 mg IV will be given 5 minutes after cord clamping in the interventional arm. | Drug | Dexamethasone |
| PlaceboThis arm will receive 2 ml of saline 5 min after cord clamping. | Drug | Placebo |
Primary outcome
Visual Analog Pain Score (VAS) 6 hours post-operatively at first rise
Time frame: 6 hours post-operatively
Visual Analog Pain Score (VAS), from 0 to 10, when patients first stand out of bed 6 hours post-operatively. A score of 0 on 10 being no pain, and a score of 10 on 10 being the worst pain imaginable.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 25237639Mohtadi A, Nesioonpour S, Salari A, Akhondzadeh R, Masood Rad B, Aslani SM. The effect of single-dose administration of dexamethasone on postoperative pain in patients undergoing laparoscopic cholecystectomy. Anesth Pain Med. 2014 Aug 13;4(3):e17872. doi: 10.5812/aapm.17872. eCollection 2014 Aug.
- Background: PubMed 24991614Shahraki AD, Feizi A, Jabalameli M, Nouri S. The effect of intravenous Dexamethasone on post-cesarean section pain and vital signs: A double-blind randomized clinical trial. J Res Pharm Pract. 2013 Jul;2(3):99-104. doi: 10.4103/2279-042X.122370.
- Background: PubMed 23022704Cardoso MM, Leite AO, Santos EA, Gozzani JL, Mathias LA. Effect of dexamethasone on prevention of postoperative nausea, vomiting and pain after caesarean section: a randomised, placebo-controlled, double-blind trial. Eur J Anaesthesiol. 2013 Mar;30(3):102-5. doi: 10.1097/EJA.0b013e328356676b.
- Individual participant dataSharing planned: Yes. If a researcher needs IPD for a meta-analysis for instance, they can contact me.
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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.
Valerie Zaphiratos, MD MSc FRCPC principal investigator
CHU Sainte-Justine, Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone (IV) in people with Pregnancy and Cesarean Delivery, run by Valerie Zaphiratos at 1 site in Canada.
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 5 inclusion and 17 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 5 Aug 2026. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Pain Score (VAS) 6 hours post-operatively at first rise (time frame: 6 hours post-operatively). 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 NCT07257406, which also lists 3 linked publications.
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 5 Aug 2026.