跳至主要内容
临床试验/NCT06425718
NCT06425718已完成不适用

Comparison of Transversalis Fascia Plane Block and Surgical Site Local Anesthetic Infiltration in Elective Cesarean Section Surgeries

Marmara University2 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2024年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device

研究概览

简要总结

Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, multimodal analgesia strategies with peripheral nerve blocks are preffered with greater safety in elective Cesarean section surgeries.

The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis fascia plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.

详细描述

After Cesarean sections, several factors play a role in the formation of postoperative pain, including parietal stimulation originating from the surgical incision, visceral stimulation originating from the peritoneum, and manipulation of intra-abdominal structures.

To enhance patients' rehabilitation during the postoperative period, promote lactation and infant care, and reduce hospital stays, the most appropriate postoperative analgesia method should be selected.

Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, regional anesthesia techniques are preferred with greater safety in elective Cesarean section surgeries.

In the postoperative period, multimodal analgesia strategies can be used for pain control, and one of these strategies is postoperative peripheral nerve blocks. Ultrasound guided transversalis fascia plane block is one of the preferred methods for postoperative analgesia in cesarean section patients.

The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients over 18 years old
  • ASA II-III patients undergoing elective cesarean section

排除标准

  • ASA IV patients
  • Patients with known neurologic or psychiatric disorders
  • Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
  • Patients with alcohol or drug addiction
  • Mentally disabled patients
  • Patients with BMI>30
  • Patients who develop massive bleeding or coagulopathy

结局指标

主要结局

Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device

时间窗: 24 hours

Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous tramadol consumption will be recorded via PCA device, then it will be documented in mg/kg units.

次要结局

  • Postoperative pain assessment with Numeric Rating Scale (NRS)(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Comparison of Postoperative Analgesia Methods in... | 临床试验