Assessing post-mastectomy pain relief: a randomised comparative study of USG erector spinae block and MTP block
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the VAS score between the two groups
研究概览
简要总结
Breast cancer is a prevalent cancer among females worldwide, and surgical procedures can cause significant postoperative pain. Effective pain management protocols, such as regional anesthesia and less invasive surgical techniques, can reduce hospital stays. Ultrasound-guided fascial plane blocks have shown efficacy in managing pain following mastectomy, but there is no consensus on the ideal volume concentration, distribution, and dermatomal coverage. Most research on ESPB mechanism of action has been conducted on cadaversic subjects yielding inconsistent results due to not all experiencing substantial dye dissemination. Methylene blue, the most commonly used dye for corpses, has faced criticism for excessive spreading and insufficient dissection technique. Assessing post mastectomy pain relief is crucial due to the significant physical and psychological burden experienced by patients. This randomized comparative study focuses on ultrasound-guided erector spinae block and mid transverse pleura block, aiming to provide insights into their benefits and limitations, aiding clinicians in selecting the most appropriate approach based on individual patient characteristics and surgical considerations.
The significance of this study lies in evaluating and comparing two effective pain management techniques, Ultrasound-Guided Erector Spinae Blockand the Modified Thoracic Paravertebral Block for post-mastectomy patients. Post-operative pain management is crucial for improving recovery, reducing opioid consumption, and enhancing patient satisfaction. By determining which technique offers superior pain relief and fewer complications, this study could influence clinical practice and provide evidence for selecting the most effective and safe method of pain control post-mastectomy. The findings may contribute to optimizing pain management strategies improving patient outcomes, and reducing healthcare costs related to post-operative care.
The research hypothesis for this randomized comparative study is that the Ultrasound-Guided Erector Spinae Block will provide superior post-mastectomy pain relief compared to the Modified Thoracic Paravertebral Block. Specifically, it is hypothesized that the ESB will result in lower pain scores, reduced opioid consumption, and improved overall recovery in the post operative period. Additionally the study aims to assess any differences in complication rates and patient satisfaction between the two pain management techniques.
The study aims to compare the analgesic efficacy of mid transverse pleura block and erector spinae block after modified radical mastectomy surgery using VAS score during the first 24hour post operative period. The objectives include comparing VAS score examining opioid consumption, time for first rescue analgesia, hemodynamic changes, and any complications post-operatively.
The study will be conducted at Department of Anaesthesiology King George Medical University Lucknow after obtaining ethical approval from the research cell The study will last for one and a half years and will use a randomised controlled trial design. The study will include two groups
Group I which will receive 20 Ml 0.25percent Bupivacaine With 10 Mg Dexamathasone
Group II which will receive 20 Ml 0.25 percent Bupivacaine With 10 Mg Dexamathasone.
Both groups will receive injections of 15ml kg 8 hourly.
Statistical analysis will be conducted using SPSS and MS Excel, with continuous variables expressed as mean standard deviation counting data as number and percentages, and unpaired t tests or non-parametric equivalents for inter-group analysis. The chi square test will be used to compare proportion data between the groups. P value less than zero will be considered statistically significant in all statistical analyses. The study aims to provide a comprehensive understanding of the benefits of bupivacaine and dexamathasone in breast surgery.
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 36.00 Year(s)(—)
- 性别
- Female
入选标准
- •Schedule For Major Breast Surgery ASA Physical Status 1 To 2 BMI Less Than 30.
排除标准
- •Prior Breast Surgeries Patients Refusal Contraindications To Regional Anaesthesia.
结局指标
主要结局
To compare the VAS score between the two groups
时间窗: To compare the VAS score between the two groups
次要结局
- Opioid consumption(Time for first rescue analgesia)
研究者
Ashu
King Georges Medical University Lucknow
