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临床试验/NCT07202416
NCT07202416招募中不适用

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

AUSL Romagna Rimini2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
52
试验地点
2
主要终点
QoR-11 questionnaire score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Erector spinae plane block (Procedure)

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.

干预措施: Intrathecal morphine (Procedure)

结局指标

主要结局

QoR-11 questionnaire score

时间窗: day 1 after surgery

Assessment of QoR-11 questionnaire score

QoR-11 questionnaire score

时间窗: day 1 after surgery

Assessment of QoR-11 questionnaire score

次要结局

  • 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)

研究者

发起方
AUSL Romagna Rimini
申办方类型
Other
责任方
Principal Investigator
主要研究者

Domenico Pietro Santonastaso

MD

AUSL Romagna Rimini

研究点 (2)

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