Comparison of Combined Spinal Epidural Analgesia and Erector Spinae Plane Block After Elective Cesarean Section (CSEA-ESP-CS)

February 11, 2026 updated by: eralp çevikkalp, Bursa City Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Emre ULUSOY
  • Phone Number: +905379492799

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combined Spinal Epidural Analgesia Group
Participants receive combined spinal-epidural analgesia for cesarean section anesthesia and postoperative pain management according to institutional protocol.
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.
Active Comparator: Erector Spinae Plane Block Group
Participants receive spinal anesthesia for cesarean section followed by ultrasound-guided bilateral erector spinae plane block for postoperative analgesia.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores Assessed by Visual Analog Scale (VAS)
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.
0, 1, 6, 12, and 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Recovery Quality Assessed by Obstetric Quality of Recovery-11 (ObsQoR-11)
Time Frame: Within the first 24 hours postoperatively
Postoperative recovery quality will be assessed using the Obstetric Quality of Recovery-11 (ObsQoR-11) questionnaire.
Within the first 24 hours postoperatively
Time to First Analgesic Requirement
Time Frame: First 24 hours postoperatively
Time elapsed from the end of surgery to the first request for rescue analgesia.
First 24 hours postoperatively
Postoperative Adverse Effects
Time Frame: Within the first 24 hours postoperatively
Incidence of postoperative nausea, vomiting, hypotension, and other complications is recorded.
Within the first 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Investigators

  • Principal Investigator: Serra Topal, Bursa City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Bursa City Hospital 005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly due to institutional policies and patient confidentiality considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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