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临床试验/NCT07374133
NCT07374133已完成不适用

Comparison of Intrathecal Morphine and Ultrasound-Guided Bilateral Transversalis Fascia Plane Block for Post-Cesarean Analgesia

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Requirement for Rescue Analgesia Within 24 Hours

研究概览

简要总结

This prospective single-center study compares intrathecal morphine and ultrasound-guided bilateral transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean delivery under spinal anesthesia. The primary outcome is the number of parturients requiring rescue analgesia within the first 24 hours postoperatively. The secondary outcomes include postoperative pain scores, rescue analgesia requirement, nausea/vomiting, pruritus, and obstetric quality of recovery (ObsQoR-11).

详细描述

This prospective single-center study investigates postoperative acute pain management in parturients aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia.Participants will be followed as a single prospective cohort, and postoperative outcomes will be compared between exposure groups defined by the routine clinical analgesic approach (intrathecal morphine or ultrasound-guided bilateral transversalis fascia plane block).A total of 60 patients are planned to be enrolled. Eligible participants are term parturients with a gestational age greater than 37 weeks, classified as American Society of Anesthesiologists (ASA) physical status II, and scheduled for elective cesarean delivery under spinal anesthesia. Patients will be excluded if they refuse participation, undergo cesarean delivery under general anesthesia, have ASA physical status greater than III, multiple pregnancy, conversion to general anesthesia after spinal anesthesia, contraindications to central or peripheral regional anesthesia techniques, body mass index greater than 35 kg/m², known allergy or hypersensitivity to local anesthetics or opioids, or significant organ dysfunction such as severe hepatic or renal disease.

In routine clinical practice, the postoperative analgesic approach is determined through shared decision-making based on patient preference and the responsible anesthesiologist's clinical assessment. Accordingly, two postoperative analgesic strategies will be compared: addition of intrathecal morphine to spinal anesthesia and ultrasound-guided bilateral transversalis fascia plane block.

Following standard ASA monitoring, spinal anesthesia is performed in the sitting position at the L4-5 interspace using a 26-gauge spinal needle. After confirmation of free cerebrospinal fluid flow, 12.5 mg of 0.5% hyperbaric bupivacaine combined with 20 micrograms of fentanyl is administered intrathecally. In the intrathecal morphine group, 100 micrograms of morphine is added to the intrathecal anesthetic solution. Sensory block level is assessed using the pinprick test, and surgery is initiated when a T6 sensory level is achieved.

In the transversalis fascia plane block group, the block is performed in the postoperative period with the patient in the supine position. An ultrasound probe is placed transversely just cranial to the iliac crest, and the abdominal wall layers, transversalis fascia, retroperitoneal fat, and peritoneum are identified. Using an in-plane needle approach, after hydrodissection with 3 mL of normal saline, 20 mL of 0.25% bupivacaine is injected into the plane deep to the transversalis fascia. The procedure is repeated on the contralateral side.

For postoperative nausea and vomiting prophylaxis, 4 mg of intravenous ondansetron is administered near skin closure, and uterotonic agents are given according to institutional protocols. Postoperative analgesia consists of 1 g intravenous paracetamol every 8 hours and intramuscular diclofenac every 12 hours. When the Numeric Rating Scale (NRS) score exceeds 4, rescue analgesia is provided with 100 mg intravenous tramadol administered as a 30-minute infusion, with a maximum daily dose of 300 mg.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Female parturients aged 18 to 45 years
  • Gestational age greater than 37 weeks
  • American Society of Anesthesiologists (ASA) physical status II
  • Scheduled for elective cesarean delivery under spinal anesthesia
  • Willingness to participate in the study

排除标准

  • Refusal to participate in the study
  • Cesarean delivery performed under general anesthesia
  • Conversion to general anesthesia after spinal anesthesia
  • ASA physical status greater than III
  • Multiple pregnancy
  • Contraindications to central or peripheral regional anesthesia techniques
  • Body mass index (BMI) greater than 35 kg/m²
  • Known allergy or hypersensitivity to local anesthetics or opioids
  • Presence of significant organ dysfunction (e.g., severe hepatic or renal disease)

研究组 & 干预措施

Elective Cesarean Delivery Cohort

This cohort includes parturients aged 18-45 years undergoing elective cesarean delivery under spinal anesthesia. Participants are followed prospectively as a single cohort. Postoperative outcomes are compared between exposure groups defined by the routine clinical analgesic approach, including intrathecal morphine or ultrasound-guided bilateral transversalis fascia plane block.

结局指标

主要结局

Requirement for Rescue Analgesia Within 24 Hours

时间窗: Within the first 24 hours postoperatively

The primary outcome is the number of participants who require rescue analgesia within the first 24 hours after cesarean delivery. Rescue analgesia is administered when the Numeric Rating Scale (NRS) pain score exceeds 4 and consists of intravenous tramadol given according to the institutional protocol.

次要结局

  • Postoperative Pain Intensity (NRS) at Rest(0, 3, 6, 12, and 24 hours postoperatively)
  • Postoperative Pain Intensity (NRS) During Activity(0, 3, 6, 12, and 24 hours postoperatively)
  • Postoperative Nausea and Vomiting (PONV) Severity Score(0, 3, 6, 12, and 24 hours postoperatively)
  • Pruritus Severity Score(0, 3, 6, 12, and 24 hours postoperatively)
  • Obstetric Quality of Recovery (ObsQoR-11T) Total Score(24 and 48 hours postoperatively)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilke Tamdogan

Asst.Prof.MD

Ondokuz Mayıs University

研究点 (1)

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