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临床试验/CTRI/2025/09/094249
CTRI/2025/09/094249尚未招募2 期

Comparison of postoperative analgesic efficacy of ultrasound guided modified pectoralis plane block and serratus anterior plane block in benign breast surgery – A randomized controlled trial

sri manakulla vinayagar medical college1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9月21日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
post extubation VAS score

研究概览

简要总结

This is a randomised controlled trial aiming to compare postoperative analgesic efficacy of two ultrasound guided modified pectoralis plane block and serratus anterior plane block in 80 female patient undergoing elective benign breast surgeries conducted at sri manakula vinayagr medical college and hosptal ,the study assesses pain relief by monitoring VAS and analgesic consumption postoperatively .Participants are randomly assigned into two equal groups Group A receiving PECS block and group B receiving SAP block both 20 ml of 0.25% bupivacaine with 8mg dexamethasone.The methodology involves strict aseptic technique and ultrasound guidance for block administration.standardized anaesthesia protocol are followed,including I gel insertion and maintained with sevoflurane ,oxygen,nitrous oxide ,postoperative pain assessed at multiple time over period of 24 hrs,with rescue analgesia administered if VAS more than 4 .Statiscal analysis using SPSS will compare pain score,time to first analgesia and total analgesic use.Ethical consideration incuded informed consent ,confidentiality,risk minimization and non monentary compensation for adverse events,with categorised as low risk and approved by IEC.This literature review support to study rationalae ,citing previous trials where both blocks improved analgesia and reduced opioid use .studies by Magoon,wang and other highlight the effectiveness of these blocks in thoracic and breast surgeries

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

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 admitted for elective benign breast surgery Patients of ASA physical status classification I and II Female patients with age of 18-65 years.

排除标准

  • Patient refusal Allergy to study drugs Surgery of breast carcinoma Emergency surgeries Local Infection Coagulopathy Spine deformity Pregnancy.

结局指标

主要结局

post extubation VAS score

时间窗: at 15 min

次要结局

  • VAS score(1, 2, 4, 6, 8, 12, 24 hours)
  • Time to first rescue analgesia(hours)
  • total analgesic requirement(over 24-hour period)

研究者

发起方
sri manakulla vinayagar medical college
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

PDEVISRI

Sri manakulla vinayagar medical college

研究点 (1)

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