Comparison of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block After Elective Cesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorBursa City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Combined Spinal Epidural Analgesia
Other interventionCombined 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 Block
Other interventionBilateral ultrasound-guided erector spinae plane block is performed following spinal anesthesia for cesarean section to provide postoperative analgesia.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Combined Spinal Epidural Analgesia GroupActive comparator 1 intervention
Group B: Erector Spinae Plane Block GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
0, 1, 6, 12, and 24 hours postoperativelySecondary outcomes
1
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.
Time frame
Within the first 24 hours postoperatively2
Time to First Analgesic Requirement
Time elapsed from the end of surgery to the first request for rescue analgesia.
Time frame
First 24 hours postoperatively3
Postoperative Adverse Effects
Incidence of postoperative nausea, vomiting, hypotension, and other complications is recorded.
Time frame
Within the first 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov