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

NCT07202416 | Recruiting

• 1 other identifier: 2223/2025 I.5/33
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Post Operative Pain

Keywords

Cesarean Section; Erector Spinae plane block; Quality of recovery

Outcome Measures

Primary Outcomes (1)

• QoR-11 questionnaire score

  Assessment of QoR-11 questionnaire score

  day 1 after surgery

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

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.

Procedure: Intrathecal morphine

Interventions

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.

Also known as: ESPB

Erector Spinae Plane Block

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.

Also known as: ITM

Intrathecal MorphineITM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult women aged 18-45 years
• ASA physical status II-III
• Full-term singleton pregnancy scheduled for elective cesarean section under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• AUSL Romagna Rimini: lead

Study Sites (1)

AUSL Romagna - Ospedale M.Bufalini

Cesena, Forlì, 47521, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Domenico P Santonastaso, MD

  AUSL Romagna - M. Bufalini Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico P Santonastaso, MD

CONTACT

+393492585491; domenicopietro.santonastaso@auslromagna.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: October 1, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

IT (1)