跳至主要内容
临床试验/NCT07490795
NCT07490795进行中(未招募)不适用

The Effects of Intrathecal Morphine and Ultrasound-Guided Bilateral Transversalis Fascia Plane Block on Postoperative Acute Pain and Patient Satisfaction in Patients Undergoing Elective Cesarean Section

Vezirköprü State Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
108
试验地点
1
主要终点
Pain intensity assessed by Numeric Rating Scale (NRS)

研究概览

简要总结

A comparison of postoperative pain levels, patient satisfaction, and side effects is planned between patients who received morphine during spinal anesthesia for cesarean section and patients who did not receive morphine but underwent bilateral transverse fascial plane block.

详细描述

It is known that cesarean deliveries are increasingly performed worldwide today. Cesarean operations can cause severe postoperative pain; inadequate control of this pain can lead to negative outcomes such as increased opioid requirements, delayed recovery, chronic pain syndrome, and postpartum depression . Furthermore, inadequate pain control may limit the mother's ability to care for her newborn, negatively affecting mother-newborn interaction, reducing breastfeeding success, and weakening the mother-baby bond.

The ideal analgesic approach should include agents that do not affect the mother's functions and have minimal transfer into breast milk. In this regard, current guidelines recommend multimodal analgesia protocols that include the use of neuraxial local anesthetics and opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and paracetamol . Although morphine administered via the neuraxial route can provide effective analgesia for the first 12-24 hours postoperatively, its use may be limited due to undesirable side effects such as delayed respiratory depression, nausea, vomiting, and pruritus . For these reasons, alternative methods aimed at reducing opioid use have come to the fore in recent years. Fascial plane blocks performed under ultrasound guidance are recommended as a complementary part of multimodal analgesia in situations where neuroaxial opioids are not used or where analgesia control is inadequate. First described by Hebbard in 2009, the Transverse Fascial Plane Block (TFPB) provides analgesia by targeting the proximal branches of the T12 and L1 nerves between the transversus abdominis muscle and the transverse fascia. TFPB is used to relieve postoperative pain, particularly after lower abdominal surgeries, cesarean sections, and appendectomies.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Woman aged 18-45
  • ASA physical status II
  • Patients undergoing cesarean section under spinal anesthesia
  • Patients received intrathecal morphine and bilateral TFB block.

排除标准

  • Contraindications to spinal anesthesia
  • ASA physical statu III- IV
  • History of hypersensitivity or allergy to the study drugs
  • Pregnancy-related diseases ( preeclampsia, eclampsia, gestational diabetes, gestational hypertension, placental abnormalities vb)
  • Obesity (body mass index > 35 kg/m2)
  • Cognitive impairment or inability to cooperate
  • Alcohol or drug dependence
  • Patients who do not provide informed consent

结局指标

主要结局

Pain intensity assessed by Numeric Rating Scale (NRS)

时间窗: 2nd, 6th, 12th, and 24th hours postoperatively

Pain intensity, will be assessed using the Numeric Rating Scale ("0" no pain, "10" most severe pain experienced) at rest and during movement (passive flexion of the legs).

次要结局

  • 1. Time to first opioid request(First 24 hours postoperatively)
  • 2. Sedation Level(2, 6, 12 and 24 hours postoperatively)
  • Incidence postoperative nausea and vomiting(First 24 hours postoperatively)
  • Incidence of pruritis(First 24 hours postoperatively)
  • Obstetric Quality of Recovery -11(ObsQoR-11) Score(24 hours postoperatively)

研究者

发起方
Vezirköprü State Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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