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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector Spinae Plane Block | Experimental | Patients in this group will receive an ultrasound-guided bilateral Erector Spinae Plane Block at the end of cesarean section, in addition to standard spinal anesthesia without intrathecal morphine. |
|
| Intrathecal MorphineITM | Active Comparator | Patients in this group will receive a standard dose of intrathecal morphine during spinal anesthesia for cesarean section. No additional fascial plane block will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector spinae plane block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| QoR-11 questionnaire score | Assessment of QoR-11 questionnaire score | day 1 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) pain scores | Assessment of Numerical Rating Scale (NRS) pain scores both at rest and during movement. NRS 0-10. 0 mean a better outcome, 10 mean a worse outcome. | 4, 6, 8, 12, and 24 hours after cesarean section |
| rescue dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenico P Santonastaso, MD | Contact | +393492585491 | domenicopietro.santonastaso@auslromagna.it |
| Name | Affiliation | Role |
|---|---|---|
| Domenico P Santonastaso, MD | AUSL Romagna - M. Bufalini Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AUSL Romagna - Ospedale M.Bufalini | Recruiting | Cesena | Forlì | 47521 | Italy |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Intrathecal morphine | Procedure | Intrathecal administration of 100 mcg of morphine in combination with a local anesthetic was performed at the time of spinal anesthesia for cesarean section. |
|
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Time to first rescue dose (interval between the block or intrathecal morphine administration and the first request for opioid analgesia). |
| day 1 after surgery |
| complications | Assessment of adverse events such as sedation, nausea, and other complications | day 1 after surgery |
| breastfeeding latch | Time from birth to first breastfeeding latch | day 1 after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |