DexamethasoneNCT07139522
Dexamethasone Versus Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Elective Caesarean Section Under Spinal Anesthesia
A study testing Bupivacaine, Dexamethasone and Magnesium sulphate in people with Dexamethasone and Magnesium Sulphate, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the efficacy of adding dexamethasone and magnesium sulfate as an adjuvant to bupivacaine in bilateral erector spinae block in postoperative pain control in patients undergoing caesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Dexamethasone, Magnesium Sulphate, Adjuvant
- What is being tested?
- Bupivacaine, Dexamethasone and Magnesium sulphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 35 years.
- Full-term, singleton, pregnant women.
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled for elective cesarean delivery under spinal anesthesia.
Who cannot join
- Refusal of the patient.
- Emergency caesarean sections.
- Patients having chronic diseases as asthma, cardiovascular disorders (Significant arrhythmias, Severe Valvular diseases, congenital heart diseases, ischemic heart disease, cardiomyopathy, deep venous thrombosis ,and pulmonary embolism)
- Renal impairment (Creatinine level ≥ 2mg/dl, urea ≥ 25mg/dL), liver impairment [Alanine aminotransferase (ALT) < 45 U/L, Aspartate aminotransferase (AST) < 45 U/L].
- Allergy to the drug enrolled in the study.
- Body mass index (BMI) ≥ 35 kg/m2.
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- Hypertensive disorders of pregnancy.
- Contraindication to spinal anesthesia, such as coagulopathy [platelet count <150.000, international normalized ratio (INR) > 1.2], or local infection.
- Requirement for conversion to general anesthesia after spinal anesthesia will also be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Esraa E Farrag, Master, 00201229244923, esraa.es1@gmail.com
Nesrine El Refaei, MD
About this study
Official title: The Efficacy of Dexamethasone Versus Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Elective Caesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial.
This study aims to compare the efficacy of adding dexamethasone and magnesium sulfate as an adjuvant to bupivacaine in bilateral erector spinae block in postoperative pain control in patients undergoing caesarean section under spinal anesthesia.
Read the detailed description
Caesarean section (CS) is the most common abdominal surgery among women worldwide. Inadequately treated postoperative pain can contribute significantly to morbidity of surgical patients, resulting in the delay of patients' recovery and ability to return to daily functional activities, increased incidence of chronic pain, and post-traumatic stress syndrome.
The ultrasound-guided erector spinae plane (ESP) block is a recently described interfascial paraspinal plane technique that was initially used by Forero et al. for providing thoracic analgesia when performed at the level of T5 transverse process. Since the pain experienced after caesarean delivery using a Pfannenstiel incision has both a somatic and visceral component.
Magnesium sulfate (MgSO4) may be helpful as an analgesic adjuvant in regional anesthesia because it improves and prolongs the analgesic effect of local anesthetics.
Dexamethasone is a potent glucocorticoid medication commonly used as an adjuvant to reduce postoperative pain. The mechanisms of perineurally administered dexamethasone are likely attributed to complex interactions, including direct inhibition of signal transmission in nociceptive C fibres, local vasoconstriction, and reduced local inflammation.
- Conditions
- Dexamethasone, Magnesium Sulphate, Adjuvant, Ultrasound, Erector Spinae Plane Block, Postoperative Analgesia
- Being tested
- Bupivacaine, Dexamethasone, Magnesium sulphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Patients will receive 20 ml of 0.25% isobaric bupivacaine.
DexamethasoneDrug
Patients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone).
Magnesium sulphateDrug
Patients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients will receive 20 ml 0.25% isobaric bupivacaine. Receives: Drug: Bupivacaine |
| Dexamethasone group | Experimental | Patients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone). Receives: Drug: Dexamethasone |
| Magnesium group | Experimental | Patients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate). Receives: Drug: Magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic requirement
Time to first analgesic requirement in the following 24 hours after cesarean delivery. It is the time elapsed between performing the assigned intervention and first morphine requirement.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Degree of pain
Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be recorded at 1, 2, 4, 6,18 and 24 h postoperatively.
Measured: 24 hours postoperatively
Obstetric Quality of Recovery
Obstetric Quality of Recovery (ObsQore) aims to measure functional recovery at 24 hours postpartum quantitatively. It includes 11 questions on a 0 to 11 scale, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing, aimed at pain management, the adverse effects of narcotics, and the perception of recovery by the patient.
Measured: 24 hours postoperatively
Total morphine consumption
Rescue analgesia in the form of morphine 0.05 mg/kg will be given when the Visual Analogue Scale (VAS) is more than 3, with a total maximum of 20mg morphine / 24hrs.
Measured: 24 hours postoperatively
Time to independent movement
Time to independent movement defined as time from performing the intervention to be able independently mobile e.g. using the bathroom, care for the baby).
Measured: 24 hours postoperatively
Incidence of complications
Incidence of complications such as nausea, vomiting, itching, urine retention, sedation (opioid sedation score), (respiratory depression (respiratory rate less than 8 breath per minute) and lower limb weakness will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Dec 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexamethasoneStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Esmaeel Sayed Farrag, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139522
- Sponsor's protocol ID
- MD-344-2023
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Dexamethasone Versus Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Elective Caesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07139522
- Acronym / sponsor ID
- MD-344-2023
- Conditions
- Dexamethasone, Magnesium Sulphate, Adjuvant, Ultrasound, Erector Spinae Plane Block, Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Aug 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.
This study aims to compare the efficacy of adding dexamethasone and magnesium sulfate as an adjuvant to bupivacaine in bilateral erector spinae block in postoperative pain control in patients undergoing caesarean section under spinal anesthesia.
Detailed description
Caesarean section (CS) is the most common abdominal surgery among women worldwide. Inadequately treated postoperative pain can contribute significantly to morbidity of surgical patients, resulting in the delay of patients' recovery and ability to return to daily functional activities, increased incidence of chronic pain, and post-traumatic stress syndrome.
The ultrasound-guided erector spinae plane (ESP) block is a recently described interfascial paraspinal plane technique that was initially used by Forero et al. for providing thoracic analgesia when performed at the level of T5 transverse process. Since the pain experienced after caesarean delivery using a Pfannenstiel incision has both a somatic and visceral component.
Magnesium sulfate (MgSO4) may be helpful as an analgesic adjuvant in regional anesthesia because it improves and prolongs the analgesic effect of local anesthetics.
Dexamethasone is a potent glucocorticoid medication commonly used as an adjuvant to reduce postoperative pain. The mechanisms of perineurally administered dexamethasone are likely attributed to complex interactions, including direct inhibition of signal transmission in nociceptive C fibres, local vasoconstriction, and reduced local inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: BupivacainePatients will receive 20 ml 0.25% isobaric bupivacaine. |
| Dexamethasone group | Experimental | Drug: DexamethasonePatients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone). |
| Magnesium group | Experimental | Drug: Magnesium sulphatePatients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 18 to 35 years.
- Full-term, singleton, pregnant women.
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled for elective cesarean delivery under spinal anesthesia.
Key exclusion criteria (9 listed)
- Refusal of the patient.
- Emergency caesarean sections.
- Patients having chronic diseases as asthma, cardiovascular disorders (Significant arrhythmias, Severe Valvular diseases, congenital heart diseases, ischemic heart disease, cardiomyopathy, deep venous thrombosis ,and pulmonary embolism)
- Renal impairment (Creatinine level ≥ 2mg/dl, urea ≥ 25mg/dL), liver impairment [Alanine aminotransferase (ALT) < 45 U/L, Aspartate aminotransferase (AST) < 45 U/L].
- Allergy to the drug enrolled in the study.
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 |
|---|---|---|
| BupivacainePatients will receive 20 ml of 0.25% isobaric bupivacaine. | Drug | Control group |
| DexamethasonePatients will receive 20 ml of (0.25% isobaric bupivacaine and 4mg of dexamethasone). | Drug | Dexamethasone group |
| Magnesium sulphatePatients will receive 20 ml of (0.25% isobaric bupivacaine and 200mg of magnesium sulphate). | Drug | Magnesium group |
Primary outcome
Time to first analgesic requirement
Time frame: 24 hours postoperatively
Time to first analgesic requirement in the following 24 hours after cesarean delivery. It is the time elapsed between performing the assigned intervention and first morphine requirement.
5 secondary outcomes
Degree of pain
Time frame: 24 hours postoperatively
Obstetric Quality of Recovery
Time frame: 24 hours postoperatively
Total morphine consumption
Time frame: 24 hours postoperatively
Time to independent movement
Time frame: 24 hours postoperatively
Incidence of complications
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, Dexamethasone and Magnesium sulphate in people with Dexamethasone and Magnesium Sulphate, run by Cairo University 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Aug 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa E Farrag, Master (00201229244923, esraa.es1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first analgesic requirement (time frame: 24 hours postoperatively). 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 24 Aug 2025.