Erector spinae plane block versus intrathecal morphine for recovery after cesarean
Comparison of Erector Spinae Plane Block and Intrathecal Morphine for Assessements of Quality of Recovery After Caesarean Section: a Randomized Controlled Trial
This will test whether a postoperative erector spinae plane (ESP) block or intrathecal morphine helps women recover better after an elective cesarean delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | AUSL Romagna Rimini Academic / other |
| Locations | 1 site (Cesena, Forlì) |
| Trial ID | NCT07202416 on ClinicalTrials.gov |
What this trial studies
This prospective interventional study compares postoperative ESP block with intrathecal morphine for analgesia after elective cesarean section in adult women. Participants who meet inclusion criteria will be assigned to receive either a postoperative ESP block or intrathecal morphine as part of a multimodal analgesic protocol. The primary outcome is quality of recovery measured by the validated QoR-11 questionnaire, with secondary outcomes including pain scores, opioid consumption, opioid-related side effects, time to mobilization, breastfeeding outcomes, and length of hospital stay. Safety exclusions include coagulation disorders, infection at the puncture site, contraindications to neuraxial analgesia, chronic opioid use, and other standard perioperative contraindications.
Who should consider this trial
Good fit: Adult women aged 18–45 with ASA II–III, full-term singleton pregnancy scheduled for elective cesarean under spinal anesthesia who can consent and use verbal pain scales are ideal candidates.
Not a fit: Patients having emergency cesarean, with coagulation disorders, chronic opioid use, allergies to study drugs, contraindications to neuraxial techniques, or inability to use pain scales are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could improve postoperative recovery and reduce opioid-related side effects after cesarean delivery.
How similar studies have performed: Intrathecal morphine is an established method for cesarean analgesia, while ESP block has shown promising but still limited and mixed evidence in obstetric settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cesena, Forlì
- AUSL Romagna - Ospedale M.Bufalini — Cesena, Forlì, Italy (Recruiting)
Study contacts
- Principal investigator: Domenico P Santonastaso, MD — AUSL Romagna - M. Bufalini Hospital
- Study coordinator: Domenico P Santonastaso, MD
- Email: domenicopietro.santonastaso@auslromagna.it
- Phone: +393492585491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.