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临床试验/NCT06771466
NCT06771466尚未招募不适用

Patients' Satisfaction for Pain Control Modalities After Caesarean Section Using Erector Spinae Plain Block Vs Lateral Quadratus Lumborum Block. a Randomized Clinical Trial

Wael Sayed El Gharabawy1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
126
试验地点
1
主要终点
To test whether the type of the plane block have an implication on the patients' satisfaction.

研究概览

简要总结

The study will compare the difference between the patient's satisfaction after Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean section alone or as part of multimodal analgesia.

The primary outcome is to test whether the type of plane block has an implication on the patients' satisfaction.

The secondary outcome is to test the difference between the two approaches on the hospital discharge

详细描述

The study will compare the difference between the patient's satisfaction after Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean section alone or as part of multimodal analgesia. The primary outcome is to evaluate whether the type of plane block has an implication on the patients' satisfaction. The secondary outcome is to evaluate the difference between the two approaches on the hospital discharge.

Detailed Description IT is well Known that both Erector spinae plane block (ESP) and quadratus lumborum block are good modality for postoperative pain control after abdominal surgeries, this study will assess which one of both modalities is superior in achieving the patient's satisfaction after caesarean section. 1. INTRODUCTION: The goals for effective post-caesarean analgesia are interrelated and include allowing maternal bonding with her neonate, facilitating postoperative mobilization to reduce the risk of thromboembolism, preserving the ability for the mother to care for her infant, minimizing opioid use, and allowing safe breastfeeding with minimal transfer of analgesics to the neonate [1]. The options for post-caesarean delivery pain control include acetaminophen, non-steroidal anti-inflammatory drugs, intravenous opioids, fascial plane blocks, and neuro-axial opioids [1, 2]. Efforts to reduce the doses of opioids prescribed after CD, both in the hospital and after discharge, are increasing. The lowest effective dose of any opioid should be used to minimize breast milk transfer and associated neonatal sedation. Neuraxial opioids are preferred to other routes of administration, when possible, to minimize maternal blood and breast milk levels [3]. If opioids are required, breastfeeding should ideally start just prior to opioid administration, as the drug concentration in breast milk rises and falls in parallel with maternal plasma levels [3]. Highly protein-bound medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and local anesthetics transfer less readily into breast milk than opioids and other lipophilic drugs [4]. A reported advantage of QL blocks is the possibility of providing better visceral analgesia compared with TAP blocks. However, the literature on the relative benefits of QL versus TAP blocks and other blocks for post-CD analgesia is conflicting. However, QL blocks can result in lower extremity weakness, particularly for the variants that involve more central injection of LA as in anterior QL [5]. Available literature regarding the use of other nerve blocks (e.g., ESP, ilio-inguinal ilio-hypogastric [IIH], transversalis fascia plane, QL blocks) has been described but is limited regarding the analgesic effect, duration of action, quality of recovery and the relation to each other. [6,7]. It is well known that dermatomal coverage from ESP blocks depends on the volume and dose of local anesthetic administered. Blocks placed at low thoracic levels (e.g., T9 to 10) should provide appropriate coverage for low transverse incision for CD.

  1. AIM/OBJECTIVES To study the difference between the patient's satisfaction after Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean section alone or as part of multimodal analgesia. The primary outcome is to assess whether the type of the plane block has an implication on the patients' satisfaction. The secondry outcome is to assess the difference between the two approaches on the hospital discharge.

  2. METHODOLOGY: Patients and Methods, Subjects and Methods, Material and Methods • Type of Study: Randomized clinical trial Study Setting: Obstetric and gynecological hospital, Faculty of medicine, Ain Shams university. • Study Period: 6 months • Study Population: Inclusion Criteria: • Parturient female • Scheduled for elective caesarean section Exclusion Criteria: • Known allergy to any of the medication used • Patients refused to participate in the study • Patients with emergency section • Patients with Bleeding disease • Patients with postpartum hemorrhage

• Sampling Method: The patients will be randomly divided into two equal groups; randomization will be done by computer-generated number lists. ALL the patients will receive spinal anesthesia after proper sterilization of the back with betadine, 2.5 ml of heavy Bupivacaine 0.5%, together with twenty-five micrograms of fentanyl at the level of L 4-5. The block was maintained at level T4. The patients will be divided into two groups: Group E includes sixty-three women; those will receive an ultrasound-guided low thoracic Erector spinae plane block at level of T9 with a total volume of 60 ml of bupivacaine 0.3% and Dexmedetomidine at a total dose of 0.5 micrograms/kg [8].

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The patient will be blind to the technique he will receive, and the care giver will be unaware of the block the patient being cared for received. Furthermore, the outcomes assessor, who is in charge of collecting the data, has no idea who received which block.

入排标准

年龄范围
— 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Parturient female
  • •Scheduled for elective cesarean section

排除标准

  • •Known allergy to any of the medications used
  • •Patients refused to participate in the study
  • •Patients with emergency section,
  • •Patients with Bleeding disease
  • •Patients with postpartum haemorrhage

研究组 & 干预措施

Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E)

Active Comparator

those will receive Bilateral ultrasound-guided low thoracic Erector spinae plane block at a level of T9 with a total volume of 60 ml of bupivacaine 0.3% and Dexmedetomidine at a total dose of 0.5 mcg/kg

干预措施: Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) (Procedure)

Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q)

Sham Comparator

Those patients will receive Bilateral ultrasound-guided Quadratus Lumborum, Lateral approach with a total volume of 60 ml of bupivacaine 0.3% and Dexmedetomidine at a total dose of 0.5 mcg/kg.

干预措施: Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q) (Procedure)

结局指标

主要结局

To test whether the type of the plane block have an implication on the patients' satisfaction.

时间窗: first 24 hours after the surgery

The patient's satisfaction with the block will be measured using a 4-point Likert assessment to the question, "Are you satisfied with the pain management done after the cesarean section?" totally disagree, disagree, agree, totally agree.

次要结局

  • to test the difference between the two approaches on the hospital discharge(24-48 hours after the surgery)

研究者

发起方
Wael Sayed El Gharabawy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wael Sayed El Gharabawy

assisstant professor of Anesthesia, Intensive care, and Pain management

Ain Shams University

研究点 (1)

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