Bursa City Hospital
Bursa, Nilüfer, 16110, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07411521
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Bursa, Nilüfer, 16110, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
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.
Bilateral ultrasound-guided erector spinae plane block is performed following spinal anesthesia for cesarean section to provide postoperative analgesia.
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.
Time frame: Within the first 24 hours postoperatively
Postoperative recovery quality will be assessed using the Obstetric Quality of Recovery-11 (ObsQoR-11) questionnaire.
Time frame: First 24 hours postoperatively
Time elapsed from the end of surgery to the first request for rescue analgesia.
Time frame: Within the first 24 hours postoperatively
Incidence of postoperative nausea, vomiting, hypotension, and other complications is recorded.
Contact information is provided by the study sponsor or research team.
Bursa City Hospital
Other Gov
Comparison of the Postoperative Analgesic Effectiveness of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block in Elective Cesarean Section
Acronym: CSEA-ESP-CS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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