Comparison of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block After Elective Cesarean Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined Spinal Epidural Analgesia, Ultrasound-Guided Erector Spinae Plane Block.
- Who it may be relevant to
- Registry conditions: Postoperative Pain After Cesarean Section. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Postoperative Analgesic Effectiveness of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block in Elective Cesarean Section
Overview
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.
Interventions
- Other Combined Spinal Epidural Analgesia
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. - Other Ultrasound-Guided Erector Spinae Plane Block
Bilateral ultrasound-guided erector spinae plane block is performed following spinal anesthesia for cesarean section to provide postoperative analgesia.
Primary outcome measures
- Postoperative Pain Scores Assessed by Visual Analog Scale (VAS) [Time frame: 0, 1, 6, 12, and 24 hours postoperatively]
Secondary outcome measures (3)
- 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]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Bursa City Hospital — Bursa
Identifiers
NCT: NCT07411521 · Bursa City Hospital 005