Actively Recruiting
Comparison of Erector Spinae Plane Block and Intrathecal Morphine for Assessments of Quality of Recovery After Cesarean Section: a Randomized Controlled Trial
Led by AUSL Romagna Rimini · Updated on 2025-10-01
52
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the quality of recovery after cesarean section in women using two different pain management approaches: the Erector Spinae Plane (ESP) Block and intrathecal morphine. Cesarean section is a common surgery that causes significant postoperative pain, which is usually managed with multiple medications. This study aims to compare these two methods to see which may better support recovery, including pain control, mobilization, breastfeeding, and hospital stay length. The study involves two groups of patients undergoing elective cesarean section with spinal anesthesia. One group will receive an ultrasound-guided bilateral ESP Block at the end of surgery using ropivacaine, while the other group will receive a standard dose of intrathecal morphine during spinal anesthesia. The study will assess pain relief and side effects from these treatments to find optimal pain management strategies. Participants will complete the Quality of Recovery-11 questionnaire on the first day after surgery to measure their recovery quality. Researchers will also monitor pain scores at various times, opioid use, side effects, time to mobilization, breastfeeding success, and hospital stay duration. The study starts in June 2025 and is led by AUSL Romagna Rimini, with participants followed closely for outcomes related to their postoperative recovery experience.
CONDITIONS
Brief Title
ESPB vs Intrathecal Morphine for Assessements of Quality of Recovery After Cesarean Section
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult women aged 18-45 years
- ASA physical status II-III
- Full-term singleton pregnancy scheduled for elective cesarean section under spinal anesthesia
You will not qualify if you...
- ASA physical status IV or higher
- Coagulation disorders
- Emergency surgery
- Preoperative infection, including at the ESPB puncture site
- Any contraindication to neuraxial analgesia
- History of chronic pain
- Use of opioids
- Allergy to local anesthetics
- Hypersensitivity to any drug used in the study
- Inability to understand or use verbal pain assessment scales
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During hospital stay following cesarean section
Participants undergo cesarean section under spinal anesthesia and receive either an ultrasound-guided bilateral Erector Spinae Plane Block at the end of surgery or intrathecal morphine during spinal anesthesia for postoperative pain control.
1 surgical visit and postoperative assessments during hospital stay
Duration - 1 day after surgery
Participants are assessed for quality of recovery, pain scores, opioid consumption, opioid-related side effects, breastfeeding outcomes, and time to mobilization after cesarean section.
Multiple assessments within 24 hours after surgery
Trial Site Locations
Total: 1 location
1
AUSL Romagna - Ospedale M.Bufalini
Cesena, Forlì, Italy, 47521
Actively Recruiting
Research Team
D
Domenico P Santonastaso, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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