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Comparison of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block After Elective Cesarean Section

Comparison of the Postoperative Analgesic Effectiveness of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block in Elective Cesarean Section

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07411521
Acronym
CSEA-ESP-CS
Enrollment
90
Registered
2026-02-17
Start date
2026-03-15
Completion date
2026-08-15
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain After Cesarean Section

Keywords

Cesarean Section, Combined Spinal Epidural Analgesia, Erector Spinae Plane Block, Postoperative Pain Management, Regional Anesthesia

Brief 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. 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

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.

Sponsors

Bursa City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Scores Assessed by Visual Analog Scale (VAS)0, 1, 6, 12, and 24 hours postoperativelyPostoperative 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.

Secondary

MeasureTime frameDescription
Postoperative Recovery Quality Assessed by Obstetric Quality of Recovery-11 (ObsQoR-11)Within the first 24 hours postoperativelyPostoperative recovery quality will be assessed using the Obstetric Quality of Recovery-11 (ObsQoR-11) questionnaire.
Time to First Analgesic RequirementFirst 24 hours postoperativelyTime elapsed from the end of surgery to the first request for rescue analgesia.
Postoperative Adverse EffectsWithin the first 24 hours postoperativelyIncidence of postoperative nausea, vomiting, hypotension, and other complications is recorded.

Countries

Turkey (Türkiye)

Contacts

CONTACTYasemin Nur Tekin
yaseminnurguney@gmail.com+905365541611
CONTACTEmre ULUSOY
+905379492799
PRINCIPAL_INVESTIGATORSerra Topal

Bursa City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026