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临床试验/NCT07137208
NCT07137208已完成不适用

Bilevel Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Analgesia After Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Total analgesic requirements of fentanyl

研究概览

简要总结

Optimizing analgesia after cesarian delivery is an essential element of enhancing maternal recovery.A multimodal analgesic approach incorporating truncal blocks can provide effective pain relief with minimal side effects for both mother and infant.The posterior TAP block may provide enhanced effect due to possible retrograde spread to the paravertebral space.The ESP block has emerged as a valuable component of multimodal pain management, providing effective postoperative analgesia for various surgeries, including cesarean delivery. We hypothesized that the bilevel ESP block will offer superior analgesic efficacy compared to the TAP block and may be a valuable addition to multimodal analgesic regimens targeting opioid use reduction.

详细描述

Optimizing analgesia after cesarian delivery is an essential element of enhancing maternal recovery, as it supports earlier mobilization, thereby reducing the risk of thromboembolic complications. A multimodal analgesic approach incorporating truncal blocks can provide effective pain relief with minimal side effects for both mother and infant. Epidural or intrathecal administration of morphine is the gold standard for post-cesarean analgesia and forms a cornerstone of multimodal pain management strategies.

In recent years, regional anesthesia techniques are increasingly employed to enhance analgesia and minimize systemic opioid use. These include local anesthetic wound infiltration, ilioinguinal/iliohypogastric nerve blocks, and intraperitoneal anesthetic instillation. Fascial plane blocks such as transversus abdominis plane (TAP), quadratus lumborum (QL), and erector spinae plane (ESP) blocks are also employed to target both somatic and visceral pain effectively.The TAP block is widely used for post-cesarean pain relief by blocking the anterior rami of spinal nerves supplying the abdominal wall through local anesthetic spread between the internal oblique and transversus abdominis muscles. While it offers effective somatic analgesia, it lacks visceral pain relief. The posterior TAP block may provide enhanced effect due to possible retrograde spread to the paravertebral space.The ESP block has emerged as a valuable component of multimodal pain management, providing effective postoperative analgesia for various surgeries, including cesarean delivery. It primarily targets the dorsal rami, with potential spread to the ventral rami through paravertebral space, offering broad and segmental analgesic coverage. The block's simplicity, safety, and opioid-sparing effects especially in low thoracic applications have contributed to its growing use in abdominal surgeries.Although early research suggests that the ESP block may reduce pain and opioid consumption following cesarean delivery, conclusive evidence of its superiority over the TAP block is still lacking. Therefore, this study aims to compare the analgesic efficacy of TAP and bilevel ESP blocks in patients undergoing cesarean delivery under spinal anesthesia.

Aim of the study:

This study aims to compare the bilateral bilevel ESP block with the bilateral TAP block for analgesia after cesarean delivery performed under spinal anesthesia.

Sample Size Calculation:

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 (Outcomes Assessor)

盲法说明

A single investigator will handle eligibility screening, informed consent, and baseline data collection. An anesthesiology resident, not involved in the study, will administer the spinal anesthesia, record intraoperative data, and prepare the block solution. The patients will be separated from the surgical field and the operators by a large opaque screen. After achieving an upper sensory level of T6 or higher, the primary investigator (who will not participate in anesthesia or postoperative care) will open group allocation envelopes and perform the block after skin closure. All blocks will be done by the same anesthesiologist. Postoperative data will be collected by independent assessors.

入排标准

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

入选标准

  • •Parturients with full term singleton pregnancy.
  • •American Society of Anesthesiologists (ASA) physical status II.

排除标准

  • •Body mass index (BMI) ≥ 35 kg/m².
  • •Cerebrovascular, cardiovascular, hepatic, or renal disease.
  • •Any contraindication to spinal anesthesia, local anesthetic or opioids.
  • •Pre-existing chronic pain syndrome or history of recent opioid exposure.
  • •Inability to comprehend or participate in pain scoring system.

研究组 & 干预措施

Bilevel ESP block group

Active Comparator

Ultrasound-guided bilevel ESP block will be performed under strict aseptic precautions and patients will be positioned in the right lateral position.

干预措施: ESP block (Procedure)

Posterior TAP block group

Active Comparator

Ultrasound-guided posterior TAP block will be performed under strict aseptic precautions and patients will be positioned the supine position.

干预措施: TAP Block (Procedure)

Bilevel ESP block group

Active Comparator

Ultrasound-guided bilevel ESP block will be performed under strict aseptic precautions and patients will be positioned in the right lateral position.

干预措施: Bupivacaine injection (Drug)

Posterior TAP block group

Active Comparator

Ultrasound-guided posterior TAP block will be performed under strict aseptic precautions and patients will be positioned the supine position.

干预措施: Bupivacaine injection (Drug)

结局指标

主要结局

Total analgesic requirements of fentanyl

时间窗: Up to 24 hours after the procedure

The amount of fentanyl consumption given as a rescue analgesia to patients will be measured all over the 24 hours.

次要结局

  • the first analgesic request time(Up to 24 hours after the procedure)
  • The intensity of postoperative pain(Up to 24 hours after the procedure)
  • Patient satisfaction(Up to 24 hours after the procedure)
  • Incidence of any adverse effects(Up to 24 hours after the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amany Hazem abdelmaksood EL-deeb

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Mansoura University

研究点 (1)

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