跳至主要内容
临床试验/NCT06808087
NCT06808087已完成不适用

Comparison of the Efficacy of Transversus Abdominis Plane Block and Erector Spinae Plane Block in the Management of Acute Appendicitis Pain in the Emergency Department

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年5月8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
96
试验地点
1
主要终点
Primary Outcome

研究概览

简要总结

This study aims to compare the effectiveness of TAP (Transversus Abdominal Plane) block, ESPB (Erector Spinal Plane Block), and tramadol in preoperative pain management for patients diagnosed with acute appendicitis and undergoing emergency surgery in the emergency department. The study will evaluate the potential of TAP block and ESPB administered to patients diagnosed with acute appendicitis in the emergency department to reduce pain intensity before surgical intervention. This study aims to contribute to practical applications to ensure optimal pain control for acute appendicitis patients under emergency department conditions.

详细描述

The study will include patients who present to the emergency department with abdominal pain, receive a diagnosis of acute appendicitis through history, physical examination, and imaging modalities, and are determined to undergo definitive surgery following general surgical consultation. Patients will be randomly assigned to three groups. Randomization will be achieved by allocating the first 5 patients to the T-50 group, the second 5 patients to the TAP-50 group, and the third 5 patients to the ESPB-50 group. Patients' pain levels will be assessed using the Numeric Rating Scale (NRS) at baseline. Subsequently, patients in the T-50 group will receive a 100 cc isotonic 0.9% NaCl (sodium chloride) solution containing 50 mg tramadol as an intravenous infusion over 15 minutes at baseline. Patients in the TAP-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by a TAP block. The steps for performing the TAP block are as follows:

Patient monitoring, preparation of the skin with 10% povidone-iodine and ensuring appropriate draping, placement of a high-frequency linear transducer transversely between the right iliac crest and subcostal margin along the midaxillary line. Structures visualized on ultrasound from superficial to deep include: skin, subcutaneous fat, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum. The TAP block will be performed in the transversus abdominis plane (TAP) between the internal oblique and transversus abdominis muscles. A 23-gauge, 60 mm blunt-tipped needle will be directed toward the TAP, and negative aspiration will be confirmed upon entry into the fascial layer. An injection of 20 mL of 0.25% bupivacaine, prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of normal saline, will be performed. Visualization of the oval spread of bupivacaine in the TAP.

Patients in the ESPB-50 group will receive a 100 cc isotonic 0.9% NaCl solution containing 50 mg tramadol as an intravenous infusion over 15 minutes at baseline, followed by an ESPB. The steps for performing the ESPB are as follows:

Patient monitoring, positioning the patient in the prone position, preparation of the skin with 10% povidone-iodine and ensuring appropriate draping, counting the transverse processes from the sacrum, placing a low-frequency curvilinear transducer parasagittally, and identifying the tip of the right transverse process at this level. Visualizing the erector spinae muscle overlying the transverse process. Inserting a 22 Gauge, 80 mm needle between the transverse process and the fascia of the erector spinae muscle. Injecting 1 to 3 milliliter (mL) of saline to confirm the separation of the erector spinae muscle fascia from the transverse process after negative aspiration, Injecting 20 mL of 0.25% bupivacaine, prepared by diluting 10 mL of 0.5% bupivacaine with 10 mL of normal saline, after another negative aspiration. Visualizing the oval spread of bupivacaine over the erector spinae muscle.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18 years and older
  • •Patients who provide written consent

排除标准

  • •Patients with abdominal wall anatomical abnormalities
  • •Patients with known local anesthetic allergies
  • •Patients with a BMI >30
  • •Patients weighing less than 45 kg
  • •Patients with coagulopathy
  • •Patients with opioid, alcohol, or substance dependence
  • •Patients with skin infections at the site of local anesthetic administration
  • •Pregnant or breastfeeding patients
  • •Hemodynamically unstable patients
  • •Patients with liver or kidney failure
  • •Patients with chronic pain conditions
  • •Patients who have difficulty cooperating or have language barriers
  • •Patients who do not provide written consent
  • •Patients under 18 years of age

研究组 & 干预措施

T-50

Patients in the T-50 group will receive a 100 cc isotonic 0.9% NaCl (normal saline) solution containing 50 mg tramadol as an intravenous infusion over 15 minutes at baseline.

干预措施: Tramadol (Drug)

ESPB-50

Patients in the ESPB-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by an ESP block.

干预措施: Tramadol (Drug)

TAP-50

Patients in the TAP-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by a TAP block.

干预措施: Transversus abdominis plane blockage (Procedure)

ESPB-50

Patients in the ESPB-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by an ESP block.

干预措施: Erector spinae plane blockage (Procedure)

TAP-50

Patients in the TAP-50 group will receive the same intravenous tramadol infusion as the T-50 group at baseline, followed by a TAP block.

干预措施: Tramadol (Drug)

结局指标

主要结局

Primary Outcome

时间窗: 1 year after study start date

Determination of whether TAP-ESP block reduces the need for opioids in the management of acute appendicitis pain in the emergency department.

次要结局

  • Secondary Outcome(1 year after study start date)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验