Study of the Effects of Rhomboid Intercostal Block on Acute Postoperative Pain Management and Chronic Pain Incidence in Patients Undergoing Oncologic Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Chronic pain incidence at postoperative third month
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of the Rhomboid Intercostal Block (RIB) on postoperative chronic pain prevalence at 3 months (primary outcome) and on acute pain control, total opioid consumption, and the incidence of opioid-related side effects within the first 24 hours (secondary outcomes) in patients undergoing elective mastectomy surgery.
The main questions it aims to answer are:
Does the application of RIB reduce the prevalence of chronic pain at 3 months postoperatively? Does RIB improve acute pain control and reduce opioid consumption and related side effects in the first 24 hours postoperatively? Researchers will compare patients who receive RIB under general anesthesia to those who do not receive the block to determine its effectiveness in reducing chronic pain prevalence, acute pain scores, and opioid-related outcomes.
详细描述
Primary Outcome Measures
The primary outcome is the prevalence of chronic pain at 3 months in patients undergoing mastectomy surgery. For patients reporting pain, additional parameters will be assessed, including:
Pain characteristics: location, frequency, intensity, and radiation. Factors that exacerbate or alleviate pain. Impact of pain on quality of life (measured on a 1-5 scale). Types and quantities of analgesics used. Secondary Outcome Measures
Acute Pain Scores:
Pain levels at 1, 6, 12, and 24 hours postoperatively at rest, measured using the Numeric Rating Scale (NRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing one of the following procedures: benign mass excisions, modified radical mastectomies (MRM), simple total mastectomies, nipple-sparing mastectomies, or skin-sparing mastectomies, regardless of additional procedures such as sentinel lymph node biopsy (SLNB), axillary lymph node dissection (ALND), or implant placement.
排除标准
- •Patients undergoing breast augmentation, reduction, or mammoplasty without a mass.
- •Patients with a BMI >
- •Emergency cases.
- •Patients with bleeding diathesis.
- •Known allergy to medications used in the study.
- •Patients with asthma.
- •Patients diagnosed with chronic kidney failure.
- •Pregnant or lactating patients.
- •Patients with chronic opioid use.
- •Patients with cooperation issues or inadequate communication ability.
- •Male patients.
结局指标
主要结局
Chronic pain incidence at postoperative third month
时间窗: from enrollment (surgery day) to the end of postoperative third month.
participants will receive a phone call from the researcher at the end of third postoperative period. They will be asked 'are you experiencing any remaining pain' and their responses will be recorded as yes or no. Patients who respond yes will be calculated between groups to find the incidence of chronic pain.
次要结局
- total morphine consumption at postoperative 24 hours(from enrollment to end of first postoperative day)
- Postoperative pain levels with Numeric Rating Scale on 1st, 6th, 12th and 24th hours(from enrollment to end of first postoperative day)
- Postoperative nausea and vomiting incidence(from enrollment to end of first postoperative day)
- Limitation on Daily Activities(from enrollment (surgery day) to the end of postoperative third month.)
- Household/Work Activities(from enrollment (surgery day) to the end of postoperative third month.)
- Social Life(from enrollment (surgery day) to the end of postoperative third month.)
- Psychological Well Being(from enrollment (surgery day) to the end of postoperative third month.)
研究者
Kamil Darcin
Assoc. Prof.
Koç University