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临床试验/NCT03947463
NCT03947463已完成不适用

Pectoral Nerves I, II and Serratus Plane Blocks in Multimodal Analgesia for Mastectomies A Randomized Clinical Trial

Shaukat Khanum Memorial Cancer Hospital & Research Centre1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Change in Pain score over 24 hours

研究概览

简要总结

Acute postoperative pain is a common problem faced by the patient after surgery, most frequently occurring in first 24 hours. Our primary objective was to assess pain score in first 24 hours in PECS block group undergoing mastectomies. Secondary objective was to observe morphine (opioids) and antiemetic consumption in post anesthetic care unit.

详细描述

Design: Observer Blinded Randomized control trial.

Place and Duration: Department of Anesthesiology, Shaukat Khanum Memorial Cancer Hospital Lahore (SKMCH), from February 2017 to December 2017

Methods: 120 patients more than 18 years, ASA I and II, planned for unilateral elective modified radical mastectomy under general anesthesia were randomly assigned to receive either general anesthesia plus Pectoral Nerve I, II and serratus (PECS) block (n = 60) or general anesthesia alone (n = 60). Pain score at fixed intervals was measured using Numeric Pain Rating Score (NPRS) after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Registered pain nurse

入排标准

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

入选标准

  • Female age 18 or older
  • (ASA) I and II
  • Scheduled to undergo elective unilateral mastectomy or Modified radical mastectomy (MRM) under general anesthesia.

排除标准

  • Patient's refusal
  • history of allergy to bupivacaine
  • contraindications to regional anaesthesia (coagulopathy and local infection),
  • BMI > 40 kg/m2,
  • patient scheduled for bilateral mastectomies
  • use of chronic pain medications
  • history of illicit drugs or alcohol abuse and history of psychiatric problems.

研究组 & 干预措施

PECS block group

Experimental

20ml of 0.25% bupivacaine was infiltrated between pectoralis major and pectoralis minor muscle and the spread was visualised on the ultrasound screen. similarly, in Serratus plane block, ultrasound probe was placed over the mid-axillary region of the thoracic cage in a sagittal plane. Ribs were identified inferiorly and laterally, until the identification of the 3rd rib in the mid axillary line. 10 ml of 0.25% bupivacaine was infiltrated in between Serratus anterior muscle and Latissimus Dorsi muscle

干预措施: PECS block (Procedure)

Control group

No Intervention

Patient were given multimodal analgesia without the regional block

结局指标

主要结局

Change in Pain score over 24 hours

时间窗: First 24 hrs

Patient's pain intensity was assessed using NPRS (Numeric Pain scoring system). Pain score was assessed at the time of arrival at PACU (0 minute) and then at 30 minutes after surgery and at discharge from PACU. Pain score was then assessed at the surgical floor at 6hours, 12hours and 24hours.

次要结局

  • Post operative morphine (opioids) consumption in PACU(first 24 hours)
  • Antiemetic consumption for treatment of PONV(120 minutes)

研究者

发起方
Shaukat Khanum Memorial Cancer Hospital & Research Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hammad Najeeb

Fellow in Anesthesia

Shaukat Khanum Memorial Cancer Hospital & Research Centre

研究点 (1)

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