Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach Total Hip Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Current pain assessed by numeric rating scale (NRS)
研究概览
简要总结
The development of minimal-incision techniques for total hip arthroplasty (THA) with preservation of soft tissue is generally associated with reduction of postoperative pain and increased patient comfort. Although this technique requires a smaller incision than other approaches used for hip surgery, adequate postoperative pain management remains crucial for enhanced recovery and early rehabilitation. The fascia iliaca block (FIB) is commonly used to enhance analgesia after hip replacement surgery, however the effect of FIB volume on analgesia quality and sensory-motor blockade have not been adequately studied. In this study, total postsurgical opioid consumption (morphine equivalents IV in hospital and oral at home) through the first postoperative week will be compared and extent and duration of sensory motor block through the 2-day inpatient stay will be evaluated.
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
- 是
入选标准
- •Male or female, at least 18 years of age at screening
- •Scheduled for unilateral DAA THA
- •American Society of Anesthesiologists (ASA) physical status 1, 2 or 3
- •Able to demonstrate sensory function by exhibiting sensitivity to light touch, pinprick and cold
- •Able to ambulate
- •Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
排除标准
- •Previous open hip surgery
- •History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
- •Contraindication to bupivacaine or morphine
- •Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to the hip surgery and which may confound the postsurgical assessments
- •Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
- •Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2
- •Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
研究组 & 干预措施
Low dosis bupivacaine
Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height)
干预措施: Marcaine 0.25 % Injectable Solution (Drug)
High dosis bupivacaine
Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height)
干预措施: Marcaine 0.25 % Injectable Solution (Drug)
Placebo
Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height)
干预措施: Sodium chloride (Drug)
结局指标
主要结局
Current pain assessed by numeric rating scale (NRS)
时间窗: Day 7
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
次要结局
- Sensory-motor blockade onset and duration(48 hours)
- Total opioid consumption(Day 7)
研究者
Catherine Vandepitte, M.D.
Medical Doctor
New York School of Regional Anesthesia