Comparison of the Postoperative Analgesic Efficacy of SAP and SPSIP Blocks in Patients Undergoing Mammoplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total opioid consumption
研究概览
简要总结
The aim is to compare the postoperative analgesic efficacy of serratus anterior plane block (SAPB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing mammoplasty surgery. To this end, a double-blind, randomized, controlled study has been designed. Female patients aged 18-65 years who will undergo mammoplasty surgery will be included in the study. Postoperative pain levels, opioid consumption, duration of analgesic requirement, and patient satisfaction will be evaluated in patients who receive fascial blocks for analgesic purposes.
详细描述
Pain management after breast surgery plays an important role in the patients' recovery process. Therefore, investigating effective and safe analgesic methods is important for improving patient comfort in the postoperative period. The serratus anterior plane block (SAPB) is a regional anesthesia technique commonly used for pain control after breast surgery. SAPB has been shown to be effective in reducing postoperative pain and decreasing opioid consumption. In addition, SAPB is easy to perform and has a low risk of complications. The serratus posterior superior intercostal plane block (SPSIPB) is a new technique developed to provide analgesia in thoracic surgeries. SPSIPB has been reported to be effective in reducing postoperative pain and decreasing analgesic consumption. However, data on the efficacy of SPSIPB in breast surgery are limited. This study aims to compare the postoperative analgesic efficacy of SAPB and SPSIPB in patients undergoing mammoplasty. For this purpose, a double-blind, randomized, controlled trial has been designed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-85 years
- •Patients undergoing elective mammoplasty
- •ASA physical status I-II
排除标准
- •Patients who refuse to participate
- •Mentally disabled patients
- •Presence of infection at the injection site
- •Patients with coagulopathy
- •History of allergy or toxicity to local anesthetics
- •Patients with uncontrolled hypertension
- •Patients with uncontrolled diabetes mellitus
- •Patients with hepatic or renal failure
- •Pregnant, breastfeeding women
研究组 & 干预措施
SAPB Group
Serratus Anterior Plane Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks for each side.
SPSIPB Group
Serratus Posterior Superior Intercostal Plane Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks for each side.
结局指标
主要结局
Total opioid consumption
时间窗: 0, 1, 6, 12 and 24 hours
Tramadol will be prepared at a concentration of 10 mg/mL, and patient-controlled analgesia (PCA) will be administered without a basal infusion, using a lock-out interval of 20 minutes and a bolus dose of 20 mg.
Postoperative pain scores (Numerical rating scale: NRS),Between 0 and 10 points (11 points in total), as the score increases, the pain intensity increases.
时间窗: 0, 1, 6, 12 and 24 hours
Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 1, 6, 12 and 24 hours.
次要结局
- Time to first analgesic requirement(24 Hour)
- Patient satisfaction score(24 Hour)
研究者
Ilker Ital
Ass. Prof. Dr
Abant Izzet Baysal University