Cesarean SectionEarly Phase 1NCT03122756
Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain
A Early Phase 1 study testing Dexamethasone and Normal Saline in people with Cesarean Section, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
*Aim of the Work This study aims to assess the efficacy of intravenous injection of dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to Oct 2018
- Phase
- Early Phase 1
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A gestational age of 38 weeks or more and planned for elective cesarean section.
- Living fetus.
- Any number of previous cesarean section.
- Intact amniotic membranes.
- No history of bleeding tendency.
Who cannot join
- Refuse to participate after counseling.
- Contraindication to spinal anesthesia (coagulopathy significant hypovolemia systemic or local sepsis - increased intracranial pressure - local anesthetic or fentanyl allergy).
- High risk pregnancies as pre-eclampsia, any medical disorder (diabetes mellitus, cardiac disease or and thyroid disease).
- Contraindication to corticosteroids e.g. systemic fungal infection
- Steroid medication one week before the operation.
- Chronic pain or daily intake of analgesic.
- Abnormal placentation e.g. placenta previa.
- Intrauterine infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospital
Cairo
Mahmoud AA ElShourbagy, MD, +201001448189, elshourbagym22@hotmail.com
About this study
Official title: Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain: Randomized Controlled Trial
*Aim of the Work This study aims to assess the efficacy of intravenous injection of dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women undergoing cesarean section.
Read the detailed description
*Research Hypothesis: In women undergoing cesarean section, intravenous injection of dexamethasone prior to spinal anesthesia may reduce post-cesarean section pain.
*Research Question: In women undergoing cesarean section, does injecting intravenous dexamethasone prior to spinal anesthesia reduce post-cesarean section pain?
- Conditions
- Cesarean Section
- Being tested
- Dexamethasone, Normal Saline
- Keywords
- Intravenous Dexamethasone, Spinal Anesthesia, Post-cesarean Section Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
Intravenous injection of dexamethasone 0.1 mg/kg maximum 8 mg (diluted with distilled water to 2 mL) just prior to administration of spinal anesthesia.
Normal SalineOther
Intravenous injection 2 mL intravenous normal saline (0.9 %) just prior to administration of spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group (D) | Experimental | will include 50 women who will receive intravenous dexamethasone. Receives: Drug: Dexamethasone |
| Group (C) | Placebo comparator | will include 50 women who will receive intravenous normal saline (0.9 %). Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in post-cesarean pain
post-cesarean pain degree scored by the patient on Visual Analogue Scale
Measured: 2, 4, 8 and 12 hours after the procedure
Secondary outcomes (5)
sensory recovery
sensory recovery time by cold object
Measured: 2, 4, 8 and 12 hours after the procedure
motor recovery
motor recovery time on Bromage scale
Measured: 2, 4, 8 and 12 hours after the procedure
nausea
postoperative nausea
Measured: 2, 4, 8 and 12 hours after the procedure
vomiting
postoperative vomiting
Measured: 2, 4, 8 and 12 hours after the procedure
shivering
postoperative shivering
Measured: 2, 4, 8 and 12 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Aug 2017
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Abdelhameed Ahmed Ali Ismail, Ain Shams Maternity Hospital
- Investigators
- Mahmoud AA ElShourbagy, MD, Study chair, Professor of Obstetrics and GynecologyDalia A Nasr, MD, Study director, Professor of Anesthesia, Intensive Care and PainBassem A Islam, MD, Study director, Lecturer in Obstetrics & GynecologyAbdelhameed AA Ismail, MBBCh, Principal investigator, Resident of Obstetrics & Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122756
- Sponsor's protocol ID
- IVD-SA-CS
- Status last verified
- Aug 2018
- First submitted
- 12 Apr 2017
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Dexamethasone Before Spinal Anesthesia on Post-cesarean Section Pain: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03122756
- Acronym / sponsor ID
- IVD-SA-CS
- Conditions
- Cesarean Section
- Keywords
- Intravenous Dexamethasone, Spinal Anesthesia, Post-cesarean Section Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 21 Apr 2017 (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.
*Aim of the Work This study aims to assess the efficacy of intravenous injection of dexamethasone prior to spinal anesthesia in reducing post-cesarean section pain in women undergoing cesarean section.
Detailed description
*Research Hypothesis: In women undergoing cesarean section, intravenous injection of dexamethasone prior to spinal anesthesia may reduce post-cesarean section pain.
*Research Question: In women undergoing cesarean section, does injecting intravenous dexamethasone prior to spinal anesthesia reduce post-cesarean section pain?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (D) | Experimental | Drug: Dexamethasonewill include 50 women who will receive intravenous dexamethasone. |
| Group (C) | Placebo comparator | Other: Normal Salinewill include 50 women who will receive intravenous normal saline (0.9 %). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (8 listed)
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 |
|---|---|---|
| DexamethasoneAlso: DecadronIntravenous injection of dexamethasone 0.1 mg/kg maximum 8 mg (diluted with distilled water to 2 mL) just prior to administration of spinal anesthesia. | Drug | Group (D) |
| Normal SalineIntravenous injection 2 mL intravenous normal saline (0.9 %) just prior to administration of spinal anesthesia. | Other | Group (C) |
Primary outcome
change in post-cesarean pain
Time frame: 2, 4, 8 and 12 hours after the procedure
post-cesarean pain degree scored by the patient on Visual Analogue Scale
5 secondary outcomes
sensory recovery
Time frame: 2, 4, 8 and 12 hours after the procedure
motor recovery
Time frame: 2, 4, 8 and 12 hours after the procedure
nausea
Time frame: 2, 4, 8 and 12 hours after the procedure
vomiting
Time frame: 2, 4, 8 and 12 hours after the procedure
shivering
Time frame: 2, 4, 8 and 12 hours after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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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.
Mahmoud AA ElShourbagy, MD study chair
Professor of Obstetrics and Gynecology
Dalia A Nasr, MD study director
Professor of Anesthesia, Intensive Care and Pain
Bassem A Islam, MD study director
Lecturer in Obstetrics & Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone and Normal Saline in people with Cesarean Section, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. 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 Egypt. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud AA ElShourbagy, MD (+201001448189, elshourbagym22@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in post-cesarean pain (time frame: 2, 4, 8 and 12 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2018.