ESPB vs Intrathecal Morphine for Assessements of Quality of Recovery After Cesarean Section
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erector spinae plane block, Intrathecal morphine.
- Who it may be relevant to
- Registry conditions: Cesarean Section, Post Operative Pain. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Erector Spinae Plane Block and Intrathecal Morphine for Assessements of Quality of Recovery After Caesarean Section: a Randomized Controlled Trial
Overview
Cesarean section is a surgical procedure that involves significant pain, which is managed through a multimodal pharmacological approach.The primary objective of the study is to evaluate the quality of hospitalization after cesarean section using the QRo11 questionnaire in patients treated with a postoperative Erector Spinae Plane Block compared to those treated with intrathecal morphine.
Detailed description
Cesarean section is one of the most common surgical procedures worldwide and is associated with significant postoperative pain. Effective pain control is crucial to enhance maternal recovery, improve mobilization, support breastfeeding, and reduce hospital stay. Traditionally, intrathecal morphine has been widely used as part of a multimodal analgesic regimen. However, its use may be limited by opioid-related side effects such as nausea, vomiting, pruritus, and respiratory depression.
Regional anesthesia techniques targeting the thoracic paravertebral space have recently been introduced to improve postoperative pain control while reducing opioid consumption. The Erector Spinae Plane (ESP) Block is a relatively simple and safe fascial plane block that has shown promising results in different surgical settings, including obstetric procedures.
The primary aim of this prospective study is to evaluate the quality of recovery after cesarean section using the validated Quality of Recovery-11 (QoR-11) questionnaire. Patients will be allocated to receive either a postoperative ESP block or intrathecal morphine as part of their analgesic protocol.
Secondary endpoints include postoperative pain scores, opioid consumption, incidence of opioid-related side effects, time to mobilization, breastfeeding outcomes, and duration of hospital stay.
This study will provide new evidence on the role of the ESP block in cesarean section and may contribute to optimizing multimodal analgesia strategies for mothers undergoing this procedure.
Interventions
- Procedure Erector spinae plane block
Ultrasound-guided Erector Spinae Plane Block performed at the T9 level with 0,375%, ropivacaine 20 mL administered bilaterally at the end of surgery for postoperative analgesia following cesarean section. - Procedure Intrathecal morphine
Intrathecal administration of 100 mcg of morphine in combination with a local anesthetic was performed at the time of spinal anesthesia for cesarean section.
Primary outcome measures
- QoR-11 questionnaire score [Time frame: day 1 after surgery]
Secondary outcome measures (4)
- Numerical Rating Scale (NRS) pain scores [Time frame: 4, 6, 8, 12, and 24 hours after cesarean section]
- rescue dose [Time frame: day 1 after surgery]
- complications [Time frame: day 1 after surgery]
- breastfeeding latch [Time frame: day 1 after surgery]
Eligibility criteria
Inclusion criteria
- Adult women aged 18-45 years
- ASA physical status II-III
- Full-term singleton pregnancy scheduled for elective cesarean section under spinal anesthesia
Exclusion criteria
- ASA ≥ IV
- Coagulation disorders
- Emergency surgery
- Preoperative infection (including infection 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- AUSL Romagna - Ospedale M.Bufalini — Cesena
Identifiers
NCT: NCT07202416 · 2223/2025 I.5/33