A Comparison Between Continuous Selective Femoral Blocks and Continuous Adductor Canal Blocks at Mid-Thigh in Total Knee Arthroplasty: What is the Best Method to Optimize Functional Achievement and Analgesia in Early Rehabilitation?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery}
研究概览
简要总结
Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer adequate or equal analgesia and may promote better performance in early rehabilitation following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve Block (FNB). A common feature of these studies has been the use of moderate to high concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when injected by a large motor nerve will inevitably cause weakness. However, the practice at our institution has long been a continuous femoral nerve block (CFNB) with a lower concentration local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have performed several thousand CFNBs using this technique which has offered the advantage of minimal motor weakness and adequate analgesia.
The primary goal of this study is to determine if our established practice of using a low concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) - infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the 48-hour postoperative period.
Definitions of the location of the adductor canal are debated heavily in literature, but they seem to agree that the middle 1/3 of the thigh contains the proximal AC while the distal 1/3 of the thigh contains the adductor hiatus - the terminal end of the AC. Our study will require placement of the continuous ACB no more distal than 20cm cephalad to the superior pole of the patella due to placement prior to surgery and the need to keep the dressing out of the operative field. The CACB catheter will also not be placed any more proximal than 20cm distal to the ASIS. In addition to other exclusion criteria, these measurements will create an exclusion for patients with an iliac-to-patella distance less than 40cm. Iliac to Patella distance (IPD) will be measured at the pre-operative interview on the day of surgery with a measuring tape. External palpable landmarks of the Anterior superior iliac spine and the superior pole of the patella will be used.
The primary outcome is based upon the ability to perform rehabilitation exercises postoperatively to the extent that criteria for discharge can be met. The primary outcome measured is the time at which a patient gains the ability to successfully perform a 75-feet unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary outcomes will be the number of days admitted prior to discharge, and average pain scores on DOS, Postoperative Day (POD) #1, and POD#2. The Day of discharge will also be used as a secondary outcome. Earlier discharge is becoming a goal of almost all healthcare systems to minimize costs.
详细描述
The three arms are as follows:
- The control group; Continuous Femoral Nerve Block - Low Dose (CFNB-LD) will be patients randomized to our standard therapy comprised of a low dose/concentration Continuous Femoral Nerve Block inserted approximately 5cm distal to the groin crease with a rate of 2ml/hr.
- Higher dose (HD) CFNB; - block placed in same location as CFNB-LD but with a higher dose rate of 4ml/hr. This higher rate could afford more pain control but may cause more quadriceps or hip flexor weakness.
- Continuous Adductor Canal Block (CACB) group will have a catheter inserted 20-30cm proximal to the superior pole of the patella, and an infusion rate of 4ml/hr, but with similar dressing to make it appear like those in group 1 and 2.
Acute Pain/Regional anesthesiologists and fellows will be performing all research procedures in the same locations that the investigators routinely perform regional nerve blocks: our preoperative holding area adjacent to the operating room suites at University of Pittsburgh Medical Center (UPMC) - Passavant.
All three groups have a set rate that will not increase. There also will be no bolus orders given on the floors, however IV and PO medications will be available to decrease discomfort. These medications are ordered to be given upon request (PRN); upon patient request. Down-regulation of doses will also not be allowed as that would cause uncertainty as to which regimen may contribute most to postoperative weakness. The only adjustment allowed will be to turn off the nerve block infusion completely on POD #1 if a dense motor block of the quadriceps or iliopsoas (hip flexor) exists, as this condition does not facilitate participation in rehabilitation exercises. The frequency of early-removal of nerve block will be recorded for all three groups.
CFNB groups Continuous Femoral Nerve Block placement: The skin of the right or left groin will be sterilized and draped under sterile conditions, the femoral nerve will be identified using ultrasound just below the inguinal crease and the local anesthetic will be infiltrated subcutaneously. The needle is inserted at the lateral edge of the probe and directed toward the nerve using ultrasound assistance. When in proximity of the nerve, 15ml of 0.2% ropivacaine will be injected through the needle with repeat aspiration every 5 ml. The nerve block catheter will be placed 3-5 cm past the needle tip and secured with steri strips and bio-occlusive dressing.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to consent to regional anesthesia and having primary total knee arthroplasty/replacement
排除标准
- •Body-Mass Index >40
- •Iliac to Patella Distance (IPD) <40cm
- •Pre-existing quadriceps weakness of involved surgical side Chronic opioid use (if using opioids within 4 weeks of surgery: excluded)
研究组 & 干预措施
Cont. Femoral Block - Low Dose Group
Arm is named by the intervention the group receives. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.
干预措施: Continuous Femoral Nerve Block (Procedure)
Cont. Femoral Block - Low Dose Group
Arm is named by the intervention the group receives. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.
干预措施: Continuous Sciatic Nerve Block (Procedure)
Cont. Femoral Block - Low Dose Group
Arm is named by the intervention the group receives. Continuous Femoral Block - Low Dose. The Block/catheter is placed about 5cm below groin at ultrasonographic apex of femoral triangle. Rate of 2ml/hr of bupivacaine 0.0625% until morning of POD#2.
干预措施: Bupivacaine (Drug)
Cont. Femoral Block - Higher Dose
Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy
干预措施: Continuous Femoral Nerve Block (Procedure)
Cont. Femoral Block - Higher Dose
Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy
干预措施: Continuous Sciatic Nerve Block (Procedure)
Cont. Femoral Block - Higher Dose
Place the CPNB in same manner as low-dose group, but rate will be 4ml/hr. Hypothesis is that this group may experience better pain control, but likely will have more dense motor blockade of thigh and less participation in physical therapy
干预措施: Bupivacaine (Drug)
Continuous Adductor Canal
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
干预措施: Nerve Block, Continuous Adductor Canal (Procedure)
Continuous Adductor Canal
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
干预措施: Continuous Sciatic Nerve Block (Procedure)
Continuous Adductor Canal
Placed at mid-thigh in proximal adductor canal near femoral artery with a bupivacaine infusion rate of 4ml/hr. Hypothesis is that this group may experience less motor blockade of thigh but may have more pain than the femoral nerve groups.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery}
时间窗: Participants will be followed for the duration of hospital stay, an average of 4 days
Ability to walk 75 feet if performed on POD#2 is usually considered the main criterion for discharge at UPMC Passavant. The patient is accompanied/supervised by physical therapist using a walker but without active intervention by therapist, unless necessary. The earliest day on which the patient achieves the 75-feet unassisted walk will be recorded for comparison among the arms/groups.
次要结局
- Average Length of Stay (to be Reported in Hours After Surgery)(Participants will be followed for the duration of hospital stay; No patients will be discharged on the day of surgery; The earliest discharge would be at 24 hours. Those hospitalized beyond 96 hours will be excluded.)
- Sustained Straight Leg Raise(Day of Surgery (DOS) - In Postoperative Recovery Unit, prior to any walking atempt)
- Postoperative Pain, Average Reported Score 11-point Scale(postoperative day one)
研究者
Kevin King, DO
Clinical Assistant Professor
University of Pittsburgh
