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临床试验/CTRI/2025/09/093987
CTRI/2025/09/093987尚未招募2 期

Comparing the quality of post operative analgesia between ultrasound guided serratus anterior plane block and pectoral nerve block in female patients undergoing breast cancer surgery - a prospective randomised single blinded study

Dr Darshini Gowramma A G1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月15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
60
试验地点
1
主要终点
While both SAP and PECS blocks are expected to potentially reduce pain in patients undergoing breast cancer surgery by providing analgesia to the lateral and anterior chest wall, we are curious to know about the time to first analgesic request, postoperative analgesia, perioperative opioid consumption and patient satisfaction

研究概览

简要总结

Breast cancer ranks first among the most common malignant neoplasms in

women. Breast cancer surgery procedures are characterized by moderate and

severe pain. Acute postoperative pain is reported in around 40% of breast cancer

patients, indicating that post operative pain treatment is insufficient. In addition,

acute postoperative pain could reduce the quality of life by increasing

the probability of post mastectomy pain syndrome. Insufficient postoperative

acute pain control is associated with increased morbidity, delayed wound healing,

lengthened hospital stay, increased side effects secondary to opioid use, chronic

pain, and high care costs. Postoperative chronic pain and long-term opioid

addiction risks after breast cancer surgery are reported to be 29 % and 11 %,

respectively.

Regional anaesthesia has an important role in the multimodal analgesia regimen

following breast surgery. The paravertebral block is considered the traditional

regional anaesthetic procedure of choice for postmastectomy pain and has shown

its ability to reduce postoperative pain scores, opioid consumption, and the

severity of chronic pain compared to general anaesthesia alone. However, this

block is also associated with negative effects and complications such as

hypotension, unintentional epidural injection, and difficulties with optimal

placement of block. In the last decade, various ultrasound (US) guided thoracic

wall blocks [pectoralis (PECS I, PECS II) nerve block, modified PECS II block,

serratus anterior plane (SAP) block] have been developed to provide reliable

analgesia in patients undergoing breast cancer surgery. The emergence of

fascial plane blocks has provided a simple, easy-to-learn alternative that lacks

many of the side effects seen with previous regional techniques used for

oncological breast procedures. In particular, the SAP and PECS blocks are

effective in breast surgery by providing analgesia to the anterior and lateral chest

walls.

In studies comparing post-mastectomy acute pain control, the thoracic

paravertebral block was outperformed by the PECS block, and the serratus anterior

plane block was reported to be less effective than the thoracic paravertebral block.

Various studies comparing PECS and SAP blocks have shown conflicting results

regarding superiority of one block over the other. Hence, this study aims to

compare the quality of post operative analgesia produced with ultrasound guided

PECS block versus the SAP block in female patients undergoing breast cancer

surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • 1 American Society of Anesthesiologists physical status I to III 2 Patients undergoing elective breast cancer surgery.

排除标准

  • 1 Allergic history to local anesthetics use 2 Psychiatric disease 3 Chronic opioid usage defined as more than 3 months preoperatively 4 Chronic pain diagnosis 5 Prolonged postoperative intubation 6 Pregnancy 7 BMI of less than 18.5 kg per meter square or more than 24.9 kg per meter square.

结局指标

主要结局

While both SAP and PECS blocks are expected to potentially reduce pain in patients undergoing breast cancer surgery by providing analgesia to the lateral and anterior chest wall, we are curious to know about the time to first analgesic request, postoperative analgesia, perioperative opioid consumption and patient satisfaction

时间窗: Right after extubation | At 2 hours post operatively | At 6 hours post operatively | At 12 hours post operatively | At 24 hours post operatively

次要结局

未报告次要终点

研究者

发起方
Dr Darshini Gowramma A G
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Darshini Gowramma A G

Karnataka Medical College and Research Institute Hubballi

研究点 (1)

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