Continuous Vs Single Shot Adductor Canal Block After ACL Reconstruction - A Randomized Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Pain at Rest
研究概览
简要总结
The investigators will be randomizing patients to either receive an adductor canal block in the operating room postoperatively as single shot of 20-30cc bupivacaine or to have a catheter inserted into the adductor canal which will be attached up to a continuous infusion pump of bupivacaine that will have a set flow rate over the next couple days. The investigators' hypothesis is that patients will have better pain control, sleep, and decreased opioid consumption with the use of a continuous infusion pump
详细描述
Screening evaluation will occur during the preoperative visit prior to surgery which generally occurs within 28 days prior to surgery. No separate screening is indicated in this study.
Patients will be asked to participate in the study if they are having ACL Reconstruction surgery with one of the orthopedic surgeons who is participating in the study. They will be informed and consented in the office or in the preoperative holding area prior to surgery.
Patients undergo ACL reconstruction at either Plainview, Franklin, Huntington, Long Island Jewish, or North Shore University Hospital.
Any medical condition that is present at the time that the participant is screened will be considered as baseline and not reported as an adverse event (AE). However, if the study participant's condition deteriorates at any time during the study, it will be recorded as an AE.
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event at each level of severity to be performed. AEs characterized as intermittent require documentation of onset and duration of each episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged >16 years old
- •In good general health as evidenced by medical history and deemed medically healthy enough to tolerate surgery by the patient's primary care physician
- •MRI with evidence of ACL tear, and wanting to have an ACL reconstruction surgery
- •Ability to take oral medication and be willing to adhere to the study intervention, including telephone calls
- •Agrees to complete surveys required on the days specified between 5-9PM
排除标准
- •Current daily opioid requirement exceeding the equivalent of 15mg morphine
- •Daily prescription of corticosteroid, tricyclic antidepressant, gabapentin, or tramadol
- •Carrying the diagnosis of chronic pain syndrome, uncontrolled anxiety, history of schizophrenia or related psychiatric disorders
- •History of alcohol or drug abuse/addiction
- •History of preexisting nerve damage in the surgical extremity
- •Knee surgery (same knee) in the previous 12 weeks
- •Anticipated knee surgery in the other knee planned in the ensuing 6 months
- •Diabetic patients with blood sugar values exceeding 250 mg/dl in the previous month
- •BMI >40Kg/m2
- •Pregnancy, which will be determined by a serum or urine HCG test on the day of surgery.
- •Incarceration
- •Inability to communicate with staff, including being unreachable by telephone
- •Revision ACL reconstruction
- •Patient reconsideration after initial agreement.
- •Non-English speaking subjects
研究组 & 干预措施
Single Shot
Patients will receive an adductor canal block in the operating room postoperatively as single shot of 20-30cc bupivacaine
干预措施: Bupivacaine (Drug)
Continuous Block
Patients will have a catheter inserted into the adductor canal which will be attached up to a continuous infusion pump of bupivacaine that will have a set flow rate over the next couple days
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Pain at Rest
时间窗: Day 14
Measured by a visual analogue scale (1-10)
Worst Pain in the past 24 hours
时间窗: Day 14
Measured by visual analogue scale 1-10
次要结局
- Daily Opioid Consumption(on post operative day 1,2,3,4,7, and 14)
- Incidence of Disturbed Sleep(on post operative day 1,2,3,4,7, and day 14)
- IKDC - International Knee Documentation Commitee Form for Knee Function(Preoperatively, 3 months, 6 months)
- Rand Short Form - 36(Preoperatively, 3 months, 6 months)