Cesarean Section, Post Operative Pain
Conditions
Keywords
Cesarean Section, Erector Spinae plane block, Quality of recovery
Brief summary
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
PROCEDUREErector 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.
PROCEDUREIntrathecal 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.
Sponsors
AUSL Romagna Rimini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoR-11 questionnaire score | day 1 after surgery | Assessment of QoR-11 questionnaire score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) pain scores | 4, 6, 8, 12, and 24 hours after cesarean section | 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. |
| rescue dose | day 1 after surgery | Time to first rescue dose (interval between the block or intrathecal morphine administration and the first request for opioid analgesia). |
| complications | day 1 after surgery | Assessment of adverse events such as sedation, nausea, and other complications |
| breastfeeding latch | day 1 after surgery | Time from birth to first breastfeeding latch |
Countries
Italy
Contacts
Primary ContactDomenico P Santonastaso, MD
Outcome results
None listed