Cesarean SectionBELLMERENCT07202416
ESPB vs Intrathecal Morphine for Assessements of Quality of Recovery After Cesarean Section
A study testing Erector spinae plane block and Intrathecal morphine in people with Cesarean Section and Post Operative Pain, run by AUSL Romagna Rimini at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section, Post Operative Pain
- What is being tested?
- Erector spinae plane block and Intrathecal morphine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult women aged 18-45 years
- ASA physical status II-III
- Full-term singleton pregnancy scheduled for elective cesarean section under spinal anesthesia
Who cannot join
- ASA ≥ IV
- Coagulation disorders
- Emergency surgery
- Preoperative infection (including infection at the ESPB puncture site)
- Any contraindication to neuraxial analgesia
- History of chronic pain
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AUSL Romagna - Ospedale M.Bufalini
Cesena, Forlì, 47521
Domenico P Santonastaso, MD, +393492585491, domenicopietro.santonastaso@auslromagna.it
About this study
Official title: Comparison of Erector Spinae Plane Block and Intrathecal Morphine for Assessements of Quality of Recovery After Caesarean Section: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Cesarean Section, Post Operative Pain
- Being tested
- Erector spinae plane block, Intrathecal morphine
- Keywords
- Cesarean Section, Erector Spinae plane block, Quality of recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Also called ESPB
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.
Intrathecal morphineProcedure or surgery
Also called ITM
Intrathecal administration of 100 mcg of morphine in combination with a local anesthetic was performed at the time of spinal anesthesia for cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Erector spinae plane block |
| 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. Receives: Procedure: Intrathecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-11 questionnaire score
Assessment of QoR-11 questionnaire score
Measured: day 1 after surgery
Secondary outcomes (4)
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.
Measured: 4, 6, 8, 12, and 24 hours after cesarean section
rescue dose
Time to first rescue dose (interval between the block or intrathecal morphine administration and the first request for opioid analgesia).
Measured: day 1 after surgery
complications
Assessment of adverse events such as sedation, nausea, and other complications
Measured: day 1 after surgery
breastfeeding latch
Time from birth to first breastfeeding latch
Measured: day 1 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start18 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domenico Pietro Santonastaso, AUSL Romagna Rimini
- Investigators
- Domenico P Santonastaso, MD, Principal investigator, AUSL Romagna - M. Bufalini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202416
- Sponsor's protocol ID
- 2223/2025 I.5/33
- Acronym
- BELLMERE
- Status last verified
- Sep 2025
- First submitted
- 15 Jul 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spinae Plane Block and Intrathecal Morphine for Assessements of Quality of Recovery After Caesarean Section: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07202416
- Acronym / sponsor ID
- BELLMERE / 2223/2025 I.5/33
- Conditions
- Cesarean Section, Post Operative Pain
- Keywords
- Cesarean Section, Erector Spinae plane block, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Procedure: Erector spinae plane blockPatients 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 | Procedure: Intrathecal morphinePatients 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult women aged 18-45 years
- ASA physical status II-III
- Full-term singleton pregnancy scheduled for elective cesarean section under spinal anesthesia
Key exclusion criteria (11 listed)
- ASA ≥ IV
- Coagulation disorders
- Emergency surgery
- Preoperative infection (including infection at the ESPB puncture site)
- Any contraindication to neuraxial analgesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane blockAlso: ESPBUltrasound-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 or surgery | Erector Spinae Plane Block |
| Intrathecal morphineAlso: ITMIntrathecal administration of 100 mcg of morphine in combination with a local anesthetic was performed at the time of spinal anesthesia for cesarean section. | Procedure or surgery | Intrathecal MorphineITM |
Primary outcome
QoR-11 questionnaire score
Time frame: day 1 after surgery
Assessment of QoR-11 questionnaire score
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Domenico P Santonastaso, MD principal investigator
AUSL Romagna - M. Bufalini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and Intrathecal morphine in people with Cesarean Section and Post Operative Pain, run by AUSL Romagna Rimini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domenico P Santonastaso, MD (+393492585491, domenicopietro.santonastaso@auslromagna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-11 questionnaire score (time frame: day 1 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.