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临床试验/CTRI/2023/05/052796
CTRI/2023/05/052796已完成不适用

Ultrasound Guided STIL Block vs ESP Block for post-operative pain management in Carcinoma Breast Patients undergoing Modified Radical Mastectomy

Institute of Medical Sciences Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年5月31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
120
试验地点
1
主要终点
severity of pain by Numerical Rating Scale

研究概览

简要总结

To assess the effectiveness and safety of SubtranverseInterligamentary (STIL) block in comparison with Erector Spinae Plane (ESP)block in patients undergoing Modified Radical Mastectomy.   Thestudy will be conducted on 120 female patients posted for MRM. Afterwritten informed consent patients would be equally and randomly placed into twogroups comprising of 54 each. Randomisation will be done by a computergenerated randomisation list.

Group I [Control Group]- Patients will be given Ultrasound GuidedErector Spinae Plane [ESP] block with 20 mL of 0.25% Levobupivacaine.

Group II [Intervention group]- Patients will be givenUltrasound Guided Subtransverse Interligamentary [STIL] block with 20 mL of0.25% Levobupivacaine.

The severity ofpain experienced by patients after surgery was assessed every 6 hours in thepostoperative period till 24 hours by an observer who is blinded to the study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • •Patients of Carcinoma breast undergoing Modified Radical Mastectomy
  • •Age group: 18-65 years.
  • •ASA grade I and II.
  • •Written informed consent.

排除标准

  • •Patient refusal or noncompliance
  • •Allergy to local anaesthetic drugs
  • •Vertebral deformity
  • •Severe obstructive or restrictive pulmonary diseases
  • •Morbid hepatic or cardiac dysfunction
  • •Unregulated DM, HTN, COPD
  • •Obesity (BMI >35 kg/m2)
  • •Clinical or laboratory evidence of infection
  • •Coagulation disorders
  • •Hemodynamically unstable patients.

结局指标

主要结局

severity of pain by Numerical Rating Scale

时间窗: 2 hrs; 6 hrs; 12 hrs; 24 hrs

Duration of analgesia

时间窗: 2 hrs; 6 hrs; 12 hrs; 24 hrs

次要结局

  • heart rate(blood pressure)

研究者

申办方类型
Government medical college

研究点 (1)

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