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临床试验/CTRI/2024/07/070122
CTRI/2024/07/070122尚未招募不适用

Comparison between ultrasound guided serratus posterior superior intercostal plane block and serratus anterior plane block for post-operative analgesia in patients undergoing modified radical mastectomy- A randomised controlled study.

Lady Hardinge Medical College and associated hospitals New Delhi Indiia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare post-operative analgesia (24hour opioid consumption) between ultrasound guided serratus posterior superior intercostal plane block and serratus anterior plane block in patients undergoing MRM (modified radical mastectomy).

研究概览

简要总结

Surgical interventions for breast cancer including breast conservation surgery, modified radical mastectomy (MRM) and lumpectomy are widespread due to the high incidence of breast cancer globally. These surgeries are essential components of breast cancer treatment. Since it affects the postoperative recovery and mobilization, pain after breast surgery is an important issue. Breast surgery presents unique pain challenges due to the complexity of the breast anatomy and the potential for extensive tissue manipulation and ineffective pain relief by oral analgesics, necessitating the exploration of advanced regional anesthesia techniques.

These include thoracic epidural or paravertebral block, intercostal nerve block, pectoral nerve blocks and the newer USG guided fascial plane blocks like erector spinae plane block (ESPB), rhomboid intercostal plane block (RIPB), serratus anterior plane block (SAPB) and Serratus posterior superior intercostal plane block (SPSIPB).

Serratus anterior plane block (SAPB) was first proposed by Blanco et al in 2013, and provides good postoperative analgesia after MRM. It blocks T2-T9 intercostal nerves and provides analgesia over the chest wall and axillary region.3

Recently an interfascial plane block technique: Serratus posterior superior intercostal plane block has been described. It is performed between serratus posterior superior muscle (SPSm) which is a periscapular muscle and intercostal muscles. Due to its features, injecting local anesthetic (LA) deeply into the SPSm results in coverage of dorsal ramus and lateral cutaneous branches of intercostal nerves at C3 to T10 levels. Given SPSIPB’s sensory dermatome, it has been demonstrated that it can provide analgesia in the hemithorax, shoulder, and back of the neck.

Although SAPB is a proven and efficacious method for providing effective post operative analgesia in patients undergoing MRM, breast cancers associated with fungating mass, local infection and inflammation may pose challenges to perform SAPB. Given SPSIPB’s sensory dermatome, it may provide analgesia for surgical procedures involving the breast. There is paucity of studies on the role of SPSIPB in pain control on breast surgeries. Therefore this study is being planned to compare the postoperative analgesia provided by the two blocks in patients undergoing MRM.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA I- III 2.Patients undergoing modified radical mastectomy.

排除标准

  • 1.Patients with contraindications like coagulopathy, bleeding diathesis and local infections at the block administration site 2.Patients with known local anesthetic drug allergies.

结局指标

主要结局

To compare post-operative analgesia (24hour opioid consumption) between ultrasound guided serratus posterior superior intercostal plane block and serratus anterior plane block in patients undergoing MRM (modified radical mastectomy).

时间窗: First 24 hours after surgery

次要结局

  • 1.The time taken to perform the block(2.Total number of skin punctures to perform the block)

研究者

发起方
Lady Hardinge Medical College and associated hospitals New Delhi Indiia
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sonam Sachdeva

Lady hardinge medical College and associated hospitals, New Delhi

研究点 (1)

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