Postoperative Pain After Cesarean SectionCSEA-ESP-CSNCT07411521
Comparison of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block After Elective Cesarean Section
A study testing Combined Spinal Epidural Analgesia and Ultrasound-Guided Erector Spinae Plane Block in people with Postoperative Pain After Cesarean Section, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain after cesarean section can significantly affect maternal recovery, early mobilization, and patient satisfaction. Regional anesthesia techniques are widely used to improve postoperative analgesia and reduce opioid consumption. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain After Cesarean Section
- What is being tested?
- Combined Spinal Epidural Analgesia and Ultrasound-Guided Erector Spinae Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 15 Aug 2026
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18-45 years
- Scheduled for elective cesarean section under regional anesthesia
- American Society of Anesthesiologists (ASA) physical status I-II
- Singleton pregnancy at term gestation
- Ability to understand the study protocol and provide written informed consent
Who cannot join
- Refusal to participate in the study
- Contraindications to regional anesthesia (coagulopathy, infection at injection site, severe hypovolemia)
- Known allergy to local anesthetics or study medications
- Body mass index (BMI) > 40 kg/m²
- Chronic opioid use or chronic pain disorders
- Neurological disorders affecting sensory assessment
- Severe obstetric complications (e.g., preeclampsia, placenta previa, fetal distress)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emre ULUSOY contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa, Nilüfer, 16110
Serra Topal, dr.serra@msn.com
About this study
Official title: Comparison of the Postoperative Analgesic Effectiveness of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block in Elective Cesarean Section
Postoperative pain after cesarean section can significantly affect maternal recovery, early mobilization, and patient satisfaction. Regional anesthesia techniques are widely used to improve postoperative analgesia and reduce opioid consumption.
Combined spinal-epidural analgesia is commonly used for cesarean section and provides effective pain control but may be associated with technical difficulties and potential complications. The erector spinae plane block is a newer ultrasound-guided regional anesthesia technique that has shown promising results for postoperative pain management in various surgical procedures.
Read more
The aim of this study is to compare the postoperative analgesic effectiveness of combined spinal-epidural analgesia and the erector spinae plane block in patients undergoing elective cesarean section.
Pain intensity will be assessed using the visual analog scale at multiple postoperative time points. Maternal recovery will be evaluated using the Obstetric Quality of Recovery-11 questionnaire. Secondary outcomes will include postoperative nausea, pruritus, time to first analgesic request, mobilization time, and patient satisfaction.
This study will help determine whether the erector spinae plane block can provide comparable or improved postoperative pain control with fewer complications compared to combined spinal-epidural analgesia.
Read the detailed description
Cesarean section is one of the most commonly performed surgical procedures worldwide and is frequently associated with moderate to severe postoperative pain. Effective postoperative analgesia is essential to promote early mobilization, maternal comfort, and improved recovery outcomes.
Combined spinal-epidural analgesia is widely used for cesarean section and provides reliable intraoperative anesthesia and postoperative pain control. However, this technique may be associated with technical complexity, prolonged procedure time, and potential complications such as hypotension, post-dural puncture headache, and catheter-related issues.
The erector spinae plane block is a relatively new ultrasound-guided interfascial plane block that provides multi-dermatomal analgesia by targeting dorsal and ventral rami of spinal nerves. Recent studies have demonstrated its effectiveness in various surgical procedures, including thoracic and abdominal surgeries.
This prospective interventional study will enroll 90 female patients aged 18 to 45 years with ASA physical status II undergoing elective cesarean section at Bursa City Hospital.
Participants will be allocated into two groups:
Group 1 will receive combined spinal-epidural analgesia according to institutional protocols.
Group 2 will receive spinal anesthesia followed by ultrasound-guided erector spinae plane block at the end of surgery.
Postoperative pain intensity will be evaluated using the visual analog scale at 0, 1, 6, 12, and 24 hours after surgery. Maternal recovery will be assessed using the Obstetric Quality of Recovery-11 questionnaire.
Secondary outcomes will include postoperative nausea and vomiting, pruritus, time to first analgesic requirement, time to mobilization, patient satisfaction, and length of hospital stay.
The study aims to determine whether the erector spinae plane block provides comparable or superior postoperative analgesia and recovery outcomes compared to combined spinal-epidural analgesia in elective cesarean section patients.
- Being tested
- Combined Spinal Epidural Analgesia, Ultrasound-Guided Erector Spinae Plane Block
- Keywords
- Cesarean Section, Combined Spinal Epidural Analgesia, Erector Spinae Plane Block, Postoperative Pain Management, Regional Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Spinal Epidural AnalgesiaOther
Combined spinal-epidural analgesia is performed for cesarean section anesthesia using standard institutional technique, providing intraoperative anesthesia and postoperative pain control through epidural catheter administration.
Ultrasound-Guided Erector Spinae Plane BlockOther
Bilateral ultrasound-guided erector spinae plane block is performed following spinal anesthesia for cesarean section to provide postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Combined Spinal Epidural Analgesia Group | Active comparator | Participants receive combined spinal-epidural analgesia for cesarean section anesthesia and postoperative pain management according to institutional protocol. Receives: Other: Combined Spinal Epidural Analgesia |
| Erector Spinae Plane Block Group | Active comparator | Participants receive spinal anesthesia for cesarean section followed by ultrasound-guided bilateral erector spinae plane block for postoperative analgesia. Receives: Other: Ultrasound-Guided Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores Assessed by Visual Analog Scale (VAS)
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at 0, 1, 6, 12, and 24 hours after surgery. Dynamic VAS scores will also be recorded during movement.
Measured: 0, 1, 6, 12, and 24 hours postoperatively
Secondary outcomes (3)
Postoperative Recovery Quality Assessed by Obstetric Quality of Recovery-11 (ObsQoR-11)
Postoperative recovery quality will be assessed using the Obstetric Quality of Recovery-11 (ObsQoR-11) questionnaire.
Measured: Within the first 24 hours postoperatively
Time to First Analgesic Requirement
Time elapsed from the end of surgery to the first request for rescue analgesia.
Measured: First 24 hours postoperatively
Postoperative Adverse Effects
Incidence of postoperative nausea, vomiting, hypotension, and other complications is recorded.
Measured: Within the first 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 posted17 Feb 2026
- Study start15 Mar 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain After 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned in parallel to one of two intervention groups: combined spinal-epidural analgesia or spinal anesthesia followed by ultrasound-guided erector spinae plane block.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, eralp çevikkalp, Bursa City Hospital
- Investigators
- Serra Topal, Principal investigator, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411521
- Sponsor's protocol ID
- Bursa City Hospital 005
- Acronym
- CSEA-ESP-CS
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to institutional policies and patient confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Effectiveness of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block in Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT07411521
- Acronym / sponsor ID
- CSEA-ESP-CS / Bursa City Hospital 005
- Keywords
- Cesarean Section, Combined Spinal Epidural Analgesia, Erector Spinae Plane Block, Postoperative Pain Management, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 17 Feb 2026 (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.
Postoperative pain after cesarean section can significantly affect maternal recovery, early mobilization, and patient satisfaction. Regional anesthesia techniques are widely used to improve postoperative analgesia and reduce opioid consumption.
Combined spinal-epidural analgesia is commonly used for cesarean section and provides effective pain control but may be associated with technical difficulties and potential complications. The erector spinae plane block is a newer ultrasound-guided regional anesthesia technique that has shown promising results for postoperative pain management in various surgical procedures.
The aim of this study is to compare the postoperative analgesic effectiveness of combined spinal-epidural analgesia and the erector spinae plane block in patients undergoing elective cesarean section.
Pain intensity will be assessed using the visual analog scale at multiple postoperative time points. Maternal recovery will be evaluated using the Obstetric Quality of Recovery-11 questionnaire. Secondary outcomes will include postoperative nausea, pruritus, time to first analgesic request, mobilization time, and patient satisfaction.
This study will help determine whether the erector spinae plane block can provide comparable or improved postoperative pain control with fewer complications compared to combined spinal-epidural analgesia.
Detailed description
Cesarean section is one of the most commonly performed surgical procedures worldwide and is frequently associated with moderate to severe postoperative pain. Effective postoperative analgesia is essential to promote early mobilization, maternal comfort, and improved recovery outcomes.
Combined spinal-epidural analgesia is widely used for cesarean section and provides reliable intraoperative anesthesia and postoperative pain control. However, this technique may be associated with technical complexity, prolonged procedure time, and potential complications such as hypotension, post-dural puncture headache, and catheter-related issues.
The erector spinae plane block is a relatively new ultrasound-guided interfascial plane block that provides multi-dermatomal analgesia by targeting dorsal and ventral rami of spinal nerves. Recent studies have demonstrated its effectiveness in various surgical procedures, including thoracic and abdominal surgeries.
This prospective interventional study will enroll 90 female patients aged 18 to 45 years with ASA physical status II undergoing elective cesarean section at Bursa City Hospital.
Participants will be allocated into two groups:
Group 1 will receive combined spinal-epidural analgesia according to institutional protocols.
Group 2 will receive spinal anesthesia followed by ultrasound-guided erector spinae plane block at the end of surgery.
Postoperative pain intensity will be evaluated using the visual analog scale at 0, 1, 6, 12, and 24 hours after surgery. Maternal recovery will be assessed using the Obstetric Quality of Recovery-11 questionnaire.
Secondary outcomes will include postoperative nausea and vomiting, pruritus, time to first analgesic requirement, time to mobilization, patient satisfaction, and length of hospital stay.
The study aims to determine whether the erector spinae plane block provides comparable or superior postoperative analgesia and recovery outcomes compared to combined spinal-epidural analgesia in elective cesarean section patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned in parallel to one of two intervention groups: combined spinal-epidural analgesia or spinal anesthesia followed by ultrasound-guided erector spinae plane block.
| Arm | Type | Receives |
|---|---|---|
| Combined Spinal Epidural Analgesia Group | Active comparator | Other: Combined Spinal Epidural AnalgesiaParticipants receive combined spinal-epidural analgesia for cesarean section anesthesia and postoperative pain management according to institutional protocol. |
| Erector Spinae Plane Block Group | Active comparator | Other: Ultrasound-Guided Erector Spinae Plane BlockParticipants receive spinal anesthesia for cesarean section followed by ultrasound-guided bilateral erector spinae plane block for postoperative analgesia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female patients aged 18-45 years
- Scheduled for elective cesarean section under regional anesthesia
- American Society of Anesthesiologists (ASA) physical status I-II
- Singleton pregnancy at term gestation
- Ability to understand the study protocol and provide written informed consent
Key exclusion criteria (7 listed)
- Refusal to participate in the study
- Contraindications to regional anesthesia (coagulopathy, infection at injection site, severe hypovolemia)
- Known allergy to local anesthetics or study medications
- Body mass index (BMI) > 40 kg/m²
- Chronic opioid use or chronic pain disorders
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 |
|---|---|---|
| Combined Spinal Epidural AnalgesiaCombined spinal-epidural analgesia is performed for cesarean section anesthesia using standard institutional technique, providing intraoperative anesthesia and postoperative pain control through epidural catheter administration. | Other | Combined Spinal Epidural Analgesia Group |
| Ultrasound-Guided Erector Spinae Plane BlockBilateral ultrasound-guided erector spinae plane block is performed following spinal anesthesia for cesarean section to provide postoperative analgesia. | Other | Erector Spinae Plane Block Group |
Primary outcome
Postoperative Pain Scores Assessed by Visual Analog Scale (VAS)
Time frame: 0, 1, 6, 12, and 24 hours postoperatively
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at 0, 1, 6, 12, and 24 hours after surgery. Dynamic VAS scores will also be recorded during movement.
3 secondary outcomes
Postoperative Recovery Quality Assessed by Obstetric Quality of Recovery-11 (ObsQoR-11)
Time frame: Within the first 24 hours postoperatively
Time to First Analgesic Requirement
Time frame: First 24 hours postoperatively
Postoperative Adverse Effects
Time frame: Within the first 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 17 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to institutional policies and patient confidentiality considerations.
Related trials for Postoperative Pain After Cesarean Section
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Lateral QL Block vs Intrathecal Morphine for Cesarean Section
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Effect of Sacral Erector Spinae Plane Block on Quality of Recovery After Cesarean Delivery: A Prospective Randomized Controlled Trial
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Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
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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.
Emre ULUSOY contact
Serra Topal principal investigator
Bursa City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Spinal Epidural Analgesia and Ultrasound-Guided Erector Spinae Plane Block in people with Postoperative Pain After Cesarean Section, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
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 7 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 17 Feb 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 Turkey (Türkiye). 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 Yasemin Nur Tekin (+905365541611, yaseminnurguney@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Scores Assessed by Visual Analog Scale (VAS) (time frame: 0, 1, 6, 12, and 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 17 Feb 2026.