Cesarean Section ComplicationsNCT06292832
Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control
A study testing Ultrasound-guided pain block and Ultrasound Machine in people with Cesarean Section Complications, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Ultrasound-guided pain block and Ultrasound Machine
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2024to 10 Sep 2024
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II women scheduled for elective CS under intrathecal anesthesia.
Who cannot join
- had local infection, bleeding disorder or known allergy to any of the study medications
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Azhar University
Asyut
Warda Ali, 010300020456, warda2001@hotmail.com
About this study
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Pain Control After Cesarean Section in Obese and Morbidly Obese Women
The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS.
Read the detailed description
The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. The present study will include ASA I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications. This study defines obesity as body mass index (BMI) ≥ 30 kg/m2 while morbid obesity is defined as BMI ≥ 40 kg/m2 assessed in the last pre-pregnancy visit (Sagi-Dain et al., 2021). The study will include normal weight women (n=86), obese women (n=86) and morbidly obese women (n=86).
- Conditions
- Cesarean Section Complications
- Being tested
- Ultrasound-guided pain block, Ultrasound Machine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided pain blockProcedure or surgery
Ultrasound-guided pain block after cesarean section
Ultrasound MachineDevice
Ultrasound machine used to guide the nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Obese Spinae Plane Block | Active comparator | Spinae Plane Block for pain control Receives: Procedure: Ultrasound-guided pain block; Device: Ultrasound Machine |
| Obese Transversus Abdominis Plane Block | Active comparator | Transversus Abdominis Plane Block for pain control. Receives: Procedure: Ultrasound-guided pain block; Device: Ultrasound Machine |
| Morbidly Obese Spinae Plane Block | Active comparator | Spinae Plane Block for pain control Receives: Procedure: Ultrasound-guided pain block; Device: Ultrasound Machine |
| Morbidly Obese Transversus Abdominis Plane Block | Active comparator | Transversus Abdominis Plane Block for pain control. Receives: Procedure: Ultrasound-guided pain block; Device: Ultrasound Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative time to rescue analgesia requirement
Time
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start10 Mar 2024 (estimated)
- Primary completion10 Sep 2024 (estimated)
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warda Demerdash Khalifa Ali, Al-Azhar University
- Investigators
- Warda Ali, Principal investigator, Al-Azhar University, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292832
- Sponsor's protocol ID
- MSR/AZAST/AIP029/22/222/8/2023
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Pain Control After Cesarean Section in Obese and Morbidly Obese Women
- ClinicalTrials.gov ID
- NCT06292832
- Acronym / sponsor ID
- MSR/AZAST/AIP029/22/222/8/2023
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 10 Sep 2024 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 5 Mar 2024 (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.
The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS.
Detailed description
The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. The present study will include ASA I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications. This study defines obesity as body mass index (BMI) ≥ 30 kg/m2 while morbid obesity is defined as BMI ≥ 40 kg/m2 assessed in the last pre-pregnancy visit (Sagi-Dain et al., 2021). The study will include normal weight women (n=86), obese women (n=86) and morbidly obese women (n=86).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Obese Spinae Plane Block | Active comparator | Procedure: Ultrasound-guided pain block, Device: Ultrasound MachineSpinae Plane Block for pain control |
| Obese Transversus Abdominis Plane Block | Active comparator | Procedure: Ultrasound-guided pain block, Device: Ultrasound MachineTransversus Abdominis Plane Block for pain control. |
| Morbidly Obese Spinae Plane Block | Active comparator | Procedure: Ultrasound-guided pain block, Device: Ultrasound MachineSpinae Plane Block for pain control |
| Morbidly Obese Transversus Abdominis Plane Block | Active comparator | Procedure: Ultrasound-guided pain block, Device: Ultrasound MachineTransversus Abdominis Plane Block for pain control. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA I-II women scheduled for elective CS under intrathecal anesthesia.
Key exclusion criteria (1 listed)
- had local infection, bleeding disorder or known allergy to any of the study medications
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 |
|---|---|---|
| Ultrasound-guided pain blockUltrasound-guided pain block after cesarean section | Procedure or surgery | Morbidly Obese Spinae Plane Block, Morbidly Obese Transversus Abdominis Plane Block, Obese Spinae Plane Block, Obese Transversus Abdominis Plane Block |
| Ultrasound MachineUltrasound machine used to guide the nerve block. | Device | Morbidly Obese Spinae Plane Block, Morbidly Obese Transversus Abdominis Plane Block, Obese Spinae Plane Block, Obese Transversus Abdominis Plane Block |
Primary outcome
postoperative time to rescue analgesia requirement
Time frame: 24 hours
Time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Warda Ali principal investigator
Al-Azhar University, Assiut, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided pain block and Ultrasound Machine in people with Cesarean Section Complications, run by Al-Azhar 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 1 inclusion and 1 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 5 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Warda Ali (00109939124, warda2001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative time to rescue analgesia requirement (time frame: 24 hours). 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 5 Mar 2024.