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临床试验/NCT06202430
NCT06202430进行中(未招募)不适用

Comparison of Ultrasound Guided High Thoracic Erector Spinae Plane Block With Shoulder Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery

Menoufia University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年8月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
36
试验地点
1
主要终点
24-hour analgesic consumption.

研究概览

简要总结

This study aimed to compare the efficacy of high thoracic-ESPB with shoulder block as analgesic options for arthroscopic shoulder surgery.

Primary outcome:

• 24-hour analgesic consumption.

Secondary outcomes:

  • Postoperative pain evaluated by: Visual Analogue Pain Scale (VAS).
  • Time to first rescue analgesia and total postoperative consumption of analgesia.
  • Effect of the block on Hemodynamics.
  • Adverse effects in the form of postoperative nausea and vomiting (PONV).
  • Patient satisfaction.

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 (Care Provider)

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All patients within the age range ≥ 21 to ≤ 70 years old.
  • •Body mass index (BMI) ≤ 35kg m
  • •ASA I, II of both sex

排除标准

  • •Refusal of the patient to the study.
  • •Infection at the site of injection.
  • •Previous known allergy to any drug used in the study by history.
  • •Renal disease [Creatinine. >3mg/dl.].
  • •Hepatic disease. [ALT>50U/L, AST >50U/L].
  • •Un cooperative or psychological unstable patients.
  • •Coagulopathy or anticoagulant therapy.
  • •Pregnancy.

研究组 & 干预措施

Ultrasound Guided High Thoracic Erector Spinae Plane Block

Active Comparator

High Thoracic-ESPB The patient was placed in the lateral decubitus. Subsequently, an ultrasound (US)-guided aseptic technique, with a high-frequency linear probe enveloped in a sterile sheath containing a thin film of US gel, was used to locate the transverse process of T2. After LA skin infiltration, a 22-G block was inserted in a cephalocaudal direction until the space between the fascia of the erector spinae and the transverse process of T2 was identified. After negative aspiration, hydro dissection using 2 mL of saline was performed. Eventually, 30 mL of the LA bupivacaine 0.25% and epinephrine 5 µg/ mL was injected.

干预措施: High Thoracic Erector Spinae Plane Block (Procedure)

Ultrasound Guided Shoulder Block

Active Comparator

Shoulder Block Suprascapular nerve block (SSNB) approach: A high-frequency linear probe was utilized across the supra-spinous fossa parallel to the spine of the scapula after skin cleaning with an antiseptic solution, if a deep block is required, a low frequency probe was required. A hyperechoic line was identified, followed by an acoustic shadow that corresponds to the floor of the supra-spinous fossa. The needle was progressed in plane from medial to lateral after local infiltration of the skin with 1% lidocaine. We directed the needle towards the lateral side of the supra-spinous fossa if the neuro-vascular bundle was not evident. After careful aspiration, 10 ml of 0.5% bupivacaine was injected under the supraspinatus muscle. Along with Axillary nerve block technique.

干预措施: Shoulder Block (Procedure)

结局指标

主要结局

24-hour analgesic consumption.

时间窗: 24 hours.

Total consumptive dose of Morphine. Patients started acetaminophen (1 g PO) before surgery. Acetaminophen infusion continued postoperatively at a dose of 1 g/6 hours. Later, 75 mg diclofenac sodium was also given intravenously twice a day, in combination with 40 mg pantoprazole once. Rescue analgesia of 2.5 mg morphine was given intravenously if the postoperative Visual Analogue Scale score was \> 3 or the patient requested additional analgesia.

次要结局

  • Visual Analogue Scale.(● Every 0.5 hour for next 2 hours. ● Every 2 hours for next 6 hours. ● Every 6 hours for remaining 24 hours post-operatively.)

研究者

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

Nevine Mostafa Soliman

Lecturer of Anesthesiology, ICU and Pain Management.

Menoufia University

研究点 (1)

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