Analgesic Efficacy of Fascia Iliaca Block for Postoperative Pain Control After Elective Hip Arthroplasty: a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 主要终点
- The total morphine consumption
研究概览
简要总结
This clinical trial aims to assess the analgesic efficacy of ultrasound-guided FIB using different analgesic combinations administered into the iliac fascia compartment. The main question it aims to answer is:
·What is the total morphine (mg) consumption at 24 hours postoperatively for each of the three groups?
The secondary questions are:
- What is the length of stay in hospital for each group?
- What is the risk of falling associated with the use of fascia iliaca block? Researchers will compare two analgesic combinations of local anesthestic naropin 0,25% versus dextrose 10% administered by fascia iliaca block for postoperative pain after total hip arthroplasty.
详细描述
The investigators plan to conduct a single-center, prospective, blinded, randomized controlled study of 150 eligible patients undergoing elective THA via a miniinvasive anterior approach starting June 2024. All patients will receive spinal anesthesia and preoperatively FIB for analgesia. The investigators define randomly three patient groups: Group 1, receiving 40 ml naropin 0,25% in saline, Group 2, receiving 40 ml naropin 0,25% in dextrose 5%, and Group 3, receiving 40 ml dextrose 10%. After the regression of spinal anesthesia, all the patients receive the same multimodal pain therapy according to the visual analog scale (VAS), including Paracetamol IV, NSAID, and morphine, according to the pain protocol in our hospital. The primary endpoint of the study is total morphine (mg) consumption at 24 hours postoperatively, and the secondary goals were length of stay and the risk of fall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication of total primary hip arthroplasty
- •ASA I-III
- •BMI<40 kg/m2
排除标准
- •Inability or refusal to sign informed consent
- •Known allergies to any of the drugs used in the study
- •Hepatic or renal insufficiency
- •Gastritis or gastroduodenal ulcer
- •Opioid dependency
- •Coagulopathy
- •Pregnancy
- •Scars in the surgery and fascia iliaca block areas
- •Clinical evidence of peripheral neuropathies.
研究组 & 干预措施
Naropin 0.25% in sodium chloride
Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in sodium chloride.
干预措施: Naropin, 0.2% Injectable Solution in Sodium chloride (Drug)
Naropin 0.25% in dextrose 5%
Preoperative supra inguinal fascia iliaca block with 40 ml naropin 0,25% in dextrose 5%.
干预措施: Naropin, 0.2% Injectable Solution in dextrose 5% (Drug)
Placebo
Preoperative supra inguinal fascia iliaca block with 40 ml dextrose 10%.
干预措施: Dextrose 10 % in Water (Drug)
结局指标
主要结局
The total morphine consumption
时间窗: 24 hours postoperatively
The total morphine consumption is measured in mg
次要结局
- The risk of fall(Up to 1 week)
- Length of stay in hospital(Up to 1 week)
研究者
Anastase Denisa
Consultant of anesthesiology and Intensive Care
Foisor Orthopedics Clinical Hospital