Adductor Canal Block Versus Femoral Nerve Block for Total Knee Arthroplasty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Mean Distance Ambulated at 48 Hours Post Operatively
研究概览
简要总结
Peripheral nerve blocks catheters of the femoral nerve have long been used for perioperative analgesia in total knee arthroplasty (TKA). These blocks provide effective analgesia and patient satisfaction for surgical pain relief. However, one of the main drawbacks to the femoral nerve block (FNB) is a denser motor block of the quadriceps muscle that can delay aggressive physical therapy and subsequent recovery from surgery. (1) Recently, there has been increasing interest in performing adductor canal blocks (ACB) with the aim of less motor blockade while providing commensurate analgesia compared to the FNB. (1,2) Current investigative reports have provided only preliminary data, and there is potential to change the standard of care for TKA as more data mounts in favor of ACBs. The goal of this study is to verify the analgesic equivalence of the two blocks, compare patient satisfaction, surgeon satisfaction, and physical therapy grading between the two blocks. Potentially, this would change the standard of care for TKA patients at this institution.
详细描述
The specific objectives of this study are to determine the effectiveness of ACB for analgesia compared to FNB as determined by patient reported VAS scores. Determine the effectiveness of ACB for analgesia compared to FNB as determined by opioid usage. Determine the effectiveness of ACB in physical therapy as determined by early ambulation distance. Determine the surgeon satisfaction via survey, and determine if there is any difference in time to discharge between the two blocks.
Participants in the investigational group will received an adductor canal nerve catheter prior to TKA surgery. Participants in the control group will receive a femoral nerve catheter prior to TKA surgery. After surgery, the patient will be seen in the recovery room to bolus the catheters and start continuous infusions of ropivacaine.
The primary endpoints include, Pain Scores (VAS) at immediate post op, 24 hours, and 48 hours, including highest, opioid consumption at 24 hours and 48 hours pain score at any given time post operatively, physical therapist assessment of patient participation 0-100, distance ambulated at 24 to 48 hours, patient satisfaction, surgeon satisfaction, and hours to discharge.
Participants will be recruited, identified, and interviewed by either the study Principal Investigator or one of the co-investigators. The interviewing investigator will confirm eligibility and the absence of any exclusionary criteria. Details of the study (including risks) will be explained to prospective participants to their satisfaction and consent forms will then be signed.
Randomization: Upon enrollment into the study, participants will be randomized 1:1 to either the investigational group (adductor canal nerve catheter) or the control group (femoral nerve catheter). Randomization will be performed using a random number generator Participants in this study will be randomized into two interventional groups. The participant in the "adductor canal nerve catheter" investigational group will receive an adductor canal block catheter placed under direct ultrasound guidance. The participants in the "femoral nerve catheter" control group will receive a femoral nerve clock catheter placed under direct ultrasound guidance with a stimulating needle. Investigational group participants in the adductor canal block arm will receive an adductor canal block catheter placed under direct ultrasound guidance as follows. Patients will be placed supine with their block limb supinated about 20 degrees to facilitate access to the anteromedial thigh. Standard noninvasive monitors will be applied, and oxygen administered via nasal canula. Parenteral midazolam and fentanyl will be titrated to patient comfort.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing total knee arthroplasty with regional anesthesia planned for postoperative analgesia.
- •Adult, 19 years of age or older
- •Patient classified as American Society of Anesthesiology (ASA) class I, II, or III
排除标准
- •Any subject not classified as an ASA I, II, or III
- •Allergy/intolerance to local anesthetic
- •Pre-existing neurologic or anatomic deficit in lower extremity on the side of the surgical site
- •Coexisting coagulopathy such as hemophilia or von Willebrand disease
研究组 & 干预措施
Adductor Canal Nerve Block
Participants will be randomized using block randomization.
干预措施: Adductor Canal Nerve Block (Procedure)
Femoral Nerve Block
Participants will be randomized using block randomization.
干预措施: Femoral Nerve Block (Drug)
结局指标
主要结局
Mean Distance Ambulated at 48 Hours Post Operatively
时间窗: From the Anesthesia Record Stop Time to 48 hours after the Anesthesia Record Stop Time
Distance ambulated in feet from the end of surgery to 48 hours postoperatively
Mean Distance Ambulated at 24 Hours Post Operatively
时间窗: Baseline up to 24 hours after the Anesthesia Record Stop Time
Distance ambulated in feet from the end of surgery to 24 hours postoperatively
次要结局
- Mean Opioid Consumption as Measured by Oral Morphine Milligram Equivalents(from baseline to two hours)
- Mean Hours to Discharge(Baseline to discharge (approximately 90 hrs))
- Mean Pain Scores 48 Hours Postoperatively(From the Anesthesia Record Stop Time to 48 hours from the Anesthesia Record Stop Time)
- Mean Opioid Consumption as Measured in Oral Morphine Equivalents(From immediately post operatively through 48 hours)
- Mean Pain Scores Immediately Preoperatively(baseline up to time of anesthesia record start time)
- Patient Satisfaction at 48 Hours Post Operatively(Baseline up to 48 hrs)
- Mean Pain Scores in PACU(Immediately post operatively, not more than 4 hours after pacu admittance)
- Mean Pain Scores at 24 Hours(From the Anesthesia Record stop time to 24 hours after Anesthesia Record stop time)
- Mean Opioid Consumption as Measured in Oral Morphine Milligram Equivalents(From immediately post operatively through 24 hours)
研究者
Promil Kukreja
Principal Investigator
University of Alabama at Birmingham