A Randomized Comparison Between Periarticular Infiltration of Local Anesthetics and Ultrasound-Guided Pericapsular Nerve Group Block for Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Presence of quadriceps motor block (defined as paralysis or paresis)
研究概览
简要总结
This randomized trial is set out to compare the postoperative strength preservation capacity of local infiltration anesthesia (LIA) and pericapsular nerve group (PENG) block after performing a primary total hip arthroplasty (THA).
The hypothesis is that LIA represents a superior alternative to PENG block in terms of strength preservation but providing effective analgesia during the first 24 postoperative hours after THA. Hence, the trial was designed as a superiority study hypothesizing a fivefold reduction in quadriceps paresis/paralysis at 3 hours.
详细描述
Patients who agree to participate in the protocol will be assigned to one group or another (LIA and PENG) through computationally generated block randomization. Outcome assessors blinded to randomization will perform all measurements.
All blocks, LIA or PENG, will be performed (or supervised) by one of the co-authors, an expert orthopedic surgeon or an expert anesthesiologist, respectively. Both blocks will be executed in the operating room, on the surgical table, under sedation, and with the barrier that separates the surgical field from the cranial area of the patient to keep the latter blind to the technique received.
All patients will undergo spinal anesthesia using 0.5% bupivacaine (10mg) plus 20 μg of fentanyl. Both groups will also receive tranexamic acid 1g intravenous (IV), ketoprofen 100mg IV, and acetaminophen 1gr IV. Propofol sedation guided with a targeted controlled infusion (TCI) model will be administered in order to obtain an adequate level of sedation.
All surgeries will be conducted by the same team of surgeons, performing a posterior approach technique in the lateral decubitus position.
In the recovery room, all patients will receive patient-controlled analgesia (morphine bolus = 1 mg; lockout interval = 8 minutes). On the surgical ward, all subjects will continue to receive acetaminophen (1 g per os every 6 hours), ketoprofen (100 mg per os every 8 hours) as well and patient-controlled analgesia (morphine bolus = 1 mg IV; lockout interval = 8 minutes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •American Society of Anesthesiologists classification 1-3
- •Body mass index between 20 and 35 (kg/m2)
排除标准
- •Adults who are unable to give their own consent
- •Pre-existing neuropathy (assessed by history and physical examination)
- •Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 01.4 or prothrombin time ≥ 50)
- •Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- •Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- •Allergy to local anesthetics (LAs) or morphine
- •Pregnancy
- •Prior surgery in the inguinal area of the corresponding surgical side
- •Previous hip arthroplasty due to hip fracture
- •Chronic pain syndromes requiring opioid intake at home
结局指标
主要结局
Presence of quadriceps motor block (defined as paralysis or paresis)
时间窗: 3 hours after post anesthesia care unit (PACU) arrival
Quadriceps motor function will be tested with the patient lying on the bed and with the hip joint at 45º and the knee at 90º. The subject will be asked to extend the knee, first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
次要结局
- Presence of quadriceps motor block (defined as paralysis or paresis)(24 hours after PACU arrival)
- Block/Infiltration-related complications(1 hour after nerve block or local anesthetic infiltration)
- Length of hospital stay(7 days after surgery)
- Readiness to discharge(4 days after surgery)
- Postoperative morphine consumption(48 hours after PACU arrival)
- Inability to perform physiotherapy due to pain(Postoperative day 2)
- Static and dynamic pain(48 hours after PACU arrival)
- Hip adduction strength(24 hours after PACU arrival)
- Time until first morphine demand(48 hours after PACU arrival)
- Inability to perform physiotherapy due to motor block(Postoperative day 2)
- Sensory block(24 hours after PACU arrival)
- Postoperative opioid related side effects(48 hours after PACU arrival)
- Duration of surgery(4 hours after skin incision)
研究者
Julian Aliste
Assistant Professor
University of Chile