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临床试验/NCT07101835
NCT07101835已完成不适用

Extent of Sensory Blockade After External Oblique Intercostal Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Extent of Sensory Blockade Measured by Cold Sensation Testing Across the Upper Abdominal Wall Following External Oblique Intercostal Block

研究概览

简要总结

n obese patients, adequate pain relief in the postoperative period is a crucial parameter that affects patient comfort and hospital stay. Improving patient comfort and recovery quality can be achieved by minimizing undesirable effects such as nausea, vomiting, and inadequate analgesia. This study aimed to evaluate the impact of the external oblique intercostal block on postoperative dermatomal distribution, acute pain scores, and opioid consumption during the first 24 hours after laparoscopic sleeve gastrectomy surgery.

详细描述

In this observational study, patients undergoing laparoscopic sleeve gastrectomy who received either superficial or deep parasternal intercostal plane blocks were evaluated for sensory distribution. Sensory assessment was conducted by a blinded investigator 30 minutes after block administration. Cold sensation testing was performed using small ice tubes applied to the abdominal wall. Sensations were categorized as Normal, Reduced, or No cold.

A successful block was defined as the loss or reduction of cold sensitivity within the expected dermatomal distribution, whereas a normal cold sensation was considered block failure. Assessments began at the midline, including the epigastric region and trocar insertion sites, and progressed laterally toward the anterior axillary line. The extent of sensory coverage was recorded on the skin surface, and marked dermatomal areas were subsequently subjected to digital analysis.

To evaluate block duration, regression of sensory changes was reassessed at 12 and 24 hours postoperatively using the same cold sensation criteria.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years

排除标准

  • Patients who did not sign the informed consent form and did not wish to participate in the study
  • Patients with a history of opioid use lasting longer than four weeks
  • Patients with chronic pain
  • Patients with a history of allergy or hypersensitivity to local anesthetics or opioids
  • Presence of severe cardiac, hepatic, or renal disease
  • Patients with alcohol or drug addiction
  • Conditions contraindicating the application of regional anesthesia
  • Patients with severe psychiatric disorders such as psychosis or dementia that limit cooperation
  • Block failure identified by dermatomal examination after the procedure
  • Patients with a STOP-BANG score > 5

研究组 & 干预措施

Group EOIB

bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

干预措施: Bilateral ultrasound guided external oblique intercostal block (EOIB) (Procedure)

Group EOIB

bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

干预措施: ıv morphine PCA (Drug)

结局指标

主要结局

Extent of Sensory Blockade Measured by Cold Sensation Testing Across the Upper Abdominal Wall Following External Oblique Intercostal Block

时间窗: 30 minutes after the blocks

Participants will undergo sensory assessment using a standardized cold sensation test at 30 minutes post-block to evaluate the maximum sensory blockade. The data will be recorded as the area of sensory loss (in cm) along the anterior abdominal wall, and the results will be aggregated to report the maximum area of sensory blockade achieved with the external oblique intercostal block. Cold sensation will be categorized as Normal Cold, Reduced Cold, or No Cold Sensation. A successful block is defined as a complete loss or reduction of cold sensitivity.

次要结局

  • The number of patients with complications(Postoperative 7 days on an average)
  • Cumulative opioid consumption in the first 24 hours after surgery(Postoperative Day 1)
  • Acute pain scores(Postoperative Day 1)
  • The incidences of postoperative nausea and vomiting (PONV)(Postoperative Day 1)
  • The number of patients who required rescue analgesia(Postoperative Day 1)
  • Regression of Sensory Blockade at 12 and 24 Hours Post-Block(Postoperative Day 1)

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

Esra Turunc

assistant professor

Ondokuz Mayıs University

研究点 (1)

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