Comparison of Erector Spinae Plane Block and Intrathecal Morphine for Assessements of Quality of Recovery After Caesarean Section: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- QoR-11 questionnaire score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts 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
- •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
Arms & Interventions
Erector Spinae Plane Block
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.
Intervention: Erector spinae plane block (Procedure)
Intrathecal MorphineITM
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.
Intervention: Intrathecal morphine (Procedure)
Outcomes
Primary Outcomes
QoR-11 questionnaire score
Time Frame: day 1 after surgery
Assessment of QoR-11 questionnaire score
QoR-11 questionnaire score
Time Frame: day 1 after surgery
Assessment of QoR-11 questionnaire score
Secondary Outcomes
- rescue dose(day 1 after surgery)
- complications(day 1 after surgery)
- breastfeeding latch(day 1 after surgery)
- Numerical Rating Scale (NRS) pain scores(4, 6, 8, 12, and 24 hours after cesarean section)
- Numerical Rating Scale (NRS) pain scores(4, 6, 8, 12, and 24 hours after cesarean section)
- rescue dose(day 1 after surgery)
- complications(day 1 after surgery)
- breastfeeding latch(day 1 after surgery)
Investigators
Domenico Pietro Santonastaso
MD
AUSL Romagna Rimini