Combined spinal-epidural versus erector spinae plane block for pain after elective cesarean
Comparison of the Postoperative Analgesic Effectiveness of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block in Elective Cesarean Section
NA · Bursa City Hospital · NCT07411521
We will test whether an erector spinae plane block provides as much or better postoperative pain relief than combined spinal-epidural analgesia for women undergoing elective cesarean section.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Bursa City Hospital (other gov) |
| Locations | 1 site (Bursa, Nilüfer) |
| Trial ID | NCT07411521 on ClinicalTrials.gov |
What this trial studies
This is a prospective interventional comparison enrolling 90 women aged 18–45 with ASA I–II status undergoing elective cesarean at Bursa City Hospital. Participants are allocated into two groups: one receiving combined spinal-epidural analgesia per institutional protocol, and the other receiving spinal anesthesia followed by an ultrasound-guided erector spinae plane block at the end of surgery. Postoperative pain intensity will be measured with the visual analog scale at multiple time points (for example 0, 1, 6, 12 hours) and recovery will be tracked using obstetric recovery metrics and opioid consumption. The study aims to compare analgesic effectiveness, recovery profiles, and potential procedure-related issues between the two approaches.
Who should consider this trial
Good fit: Women aged 18–45 with singleton term pregnancy, ASA physical status I–II, scheduled for elective cesarean under regional anesthesia who can give informed consent are ideal candidates.
Not a fit: Patients with contraindications to regional anesthesia, BMI > 40 kg/m², chronic opioid use or chronic pain disorders, significant neurological disorders, or severe obstetric complications are unlikely to benefit from or be eligible for this comparison.
Why it matters
Potential benefit: If successful, the erector spinae plane block could offer similar or improved pain relief with fewer technical challenges and lower opioid requirements after cesarean delivery.
How similar studies have performed: Recent small studies and case series have reported promising analgesic effects of the erector spinae plane block in abdominal and obstetric surgeries, but direct head-to-head comparisons with combined spinal-epidural analgesia remain limited.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bursa, Nilüfer
- Bursa City Hospital — Bursa, Nilüfer, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Serra Topal — Bursa City Hospital
- Study coordinator: Yasemin Nur Tekin
- Email: yaseminnurguney@gmail.com
- Phone: +905365541611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postoperative Pain After Cesarean Section, Cesarean Section, Combined Spinal Epidural Analgesia, Erector Spinae Plane Block, Postoperative Pain Management, Regional Anesthesia