The Effect of Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Chronic postsurgical pain after hip fracture surgery
研究概览
简要总结
This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek.
Half of the patients will not receive fascia iliaca compartment block.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III (American Society of Anesthesiologists classification)
- •intertrochanteric fractures
- •fractures of femoral neck
排除标准
- •existing pain in hip Joint to be operated
- •cognitive or mental disorder
- •administration of analgesic drugs prior surgery
- •contraindications of spinal anesthesia
- •refusal to participate in the study
研究组 & 干预措施
Fascia iliaca compartment block (FICB)
Under ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca.
干预措施: Fascia iliaca compartment block (Drug)
Fascia iliaca compartment block (FICB)
Under ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca.
干预措施: Ropivacaine (Drug)
Fascia iliaca compartment block (FICB)
Under ultrasound guidance performing fascia iliaca compartment block, in which 40 ml ropivacaine 0,5% are injected under the fascia iliaca.
干预措施: ultrasound (Device)
Placebo (not FICB)
Half of the patients will not receive FICB
干预措施: Placebo (Drug)
结局指标
主要结局
Chronic postsurgical pain after hip fracture surgery
时间窗: 6 months
3 and 6 months after surgery the patient or patient's relative will be asked on telephone to complete Von Korff Graded Chronic scale modified for hip pain
Acute postsurgical pain after hip fracture surgery
时间窗: 48 hours
Acute pain will be evaluated using the Numeric Rating Scale- NRS (0=no pain, 10= Extremely strong pain) at rest and in motion.
次要结局
未报告次要终点
研究者
Maria Diakomi
Anesthesiologist
Asklepieion Voulas General Hospital