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NCT Number: NCT07202416

ESPB vs Intrathecal Morphine for Assessements of Quality of Recovery After Cesarean Section

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.

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Key information

Conditions

Cesarean Section Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AUSL Romagna - Ospedale M.Bufalini

Cesena, Forlì, 47521, Italy

Location status: Recruiting

Location contact

Domenico P Santonastaso, MD

CONTACT

[email protected]

+393492585491

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ESPB

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.

Other names: ITM

Primary outcomes

  1. QoR-11 questionnaire score

    Time frame: day 1 after surgery

    Assessment of QoR-11 questionnaire score

Secondary outcomes

  1. Numerical Rating Scale (NRS) pain scores

    Time frame: 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.

  2. rescue dose

    Time frame: day 1 after surgery

    Time to first rescue dose (interval between the block or intrathecal morphine administration and the first request for opioid analgesia).

  3. complications

    Time frame: day 1 after surgery

    Assessment of adverse events such as sedation, nausea, and other complications

  4. breastfeeding latch

    Time frame: day 1 after surgery

    Time from birth to first breastfeeding latch

Study contacts

Contact information is provided by the study sponsor or research team.

Domenico P Santonastaso, MD

CONTACT

[email protected]

+393492585491

Sponsors and collaborators

Lead sponsor

AUSL Romagna Rimini

Other

Registry information

Official study title

Comparison of Erector Spinae Plane Block and Intrathecal Morphine for Assessements of Quality of Recovery After Caesarean Section: a Randomized Controlled Trial

Acronym: BELLMERE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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