Evaluation of the Effectiveness of Subcutaneous and Intracutaneous Local Anesthesia for Postoperative Analgesia in Patients Undergoing Cesarean Section Under General Anesthesia: a Prospective Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 主要终点
- Visual analogue scale
研究概览
简要总结
In the management of pain after Caesarean section (C/S), opioid or nonsteroidal anti-inflammatory parenteral drugs are applied. These drugs are insufficient in some cases and may cause pain attacks during the day. Higher doses and repeated drug applications or combined drug administration may cause drug side effects and interactions. Alternative applications to provide analgesia include subcutaneous and intracutaneous local anesthetic application to the wound site. Although the effectiveness of these applications has been tested in individuals with different clinical characteristics and has been shown to be largely more successful, they have not been sufficiently introduced into routine practice. There is a need to review the pain methods suggested in the literature and develop new solutions that can be applied more optimally, improve the patient's pain management in the postoperative period, and increase their quality of life and satisfaction.
It aims to evaluate the success of subcutaneous and intracutaneous local anesthesia applications compared to traditional applications, and to find the most optimal management.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy pregnancy,
- •Term (>37 weeks) and preterm (28-34 weeks) pregnancy,
- •Cases that received general anesthesia for cesarean section,
- •Cases with and without labor,
- •Cases with and without obesity,
- •Cases that had their first or second cesarean section
排除标准
- •Pregnant women under 19 years of age,
- •Those with a history of allergic reactions to analgesics to be used,
- •Stillbirth,
- •Surgical complications during C/S and placement of an abdominal drain,
- •No head or breech presentation during C/S,
- •Occiput posterior presentation during C/S,
- •Anhydramnios and polyhydramnios,
- •Allergic reactions to the drugs used in the study, alcohol dependence, drug and substance dependence, chronic pain syndrome, neuropathic pain disorder history,
- •History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, psychiatric, metabolic disease.
研究组 & 干预措施
Subcutaneous local anesthesia group
who received subcutaneous local anesthesia at the end of C/S surgery
干预措施: neural therapy (Drug)
Intracutaneous local anesthesia group
who received intracutaneous local anesthesia at the end of C/S surgery
干预措施: neural therapy (Drug)
Parenteral analgesia group
who received parenteral analgesia after C/S surgery
干预措施: neural therapy (Drug)
结局指标
主要结局
Visual analogue scale
时间窗: 48 hours
1=no pain, 10=worst pain
次要结局
未报告次要终点
研究者
Emine Yilmaz Guler
Principal Investigator
Haseki Training and Research Hospital