Total Regional Anesthesia Techniques Resulting in up and Early Discharge Following Knee Surgery: An Opioid Reduction Plan for Transitional Pain at Home.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Scoring on the Quality of Recovery-15 Survey
研究概览
简要总结
The use of periarticular injection and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing total knee arthroplasty. The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone, with respect to quality of recovery, functional return, discharge readiness, and short and long term post-operative narcotic use.
详细描述
This study is a double blinded, randomized control trial. In order to create a blinded study, each participant will receive two injections; a single shot adductor canal block (ACB) and a periarticular injection (PI). All syringes will be non-identifiable to the surgeon, anesthetist and the patient.
Specifically, the two arms are:
Arm 1: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Ropivacaine)
Arm 2: PI (Ropivacaine + Ketorolac + Epinepherine) + ACB (Normal Saline)
The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone. The investigators hypothesize that the addition of an adductor canal block will translate to a superior quality of recovery, as well as an improvement in functional return, discharge readiness and less short-term and long-term post-operative narcotic use.
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)
盲法说明
Sealed envelopes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring primary total knee arthroplasty
- •Patients interested in being part of the study
- •Eligible to receive spinal anesthesia
排除标准
- •Age < 18 years
- •BMI > 40 kg/m2
- •Deemed unsuitable for regional anesthesia
- •Planned general anesthesia
- •Hepatic insufficiency/Intolerance to acetaminophen
- •Renal insufficiency (defined by eGFR <60)
- •Chronic opioid use (individuals requiring the equivalent of 1 mg or more of intravenous morphine, or 3 mg or more of oral morphine, per hour for greater than 1 month)
- •Sulpha allergy
- •Allergy or intolerance to trial medications
- •Clinical Frailty Scale Score > 4
- •Surgery scheduled on a weekend
研究组 & 干预措施
Periarticular Injection + Adductor Canal Block (Local Anesthestic)
The experimental arm with receive both the periarticular injection and the adductor canal block.
The periarticular injection will be performed by the surgeon and will consist of 100 mL of injectate being distributed in the following manner: 30 mL to the posterior capsule, 10 mL to the medial collateral ligament, 10mL to the lateral collateral ligament (ensuring not to infiltrate common peroneal nerve), 20mL to the quadriceps and anterior capsule, and 30 mL to the subcutaneous tissue. The periarticular injection will consist of 250 mg of ropivacaine, 30 mg of ketorolac, and 0.5 mg of epinephrine.
The adductor canal block will be completed by the anesthesiologist after spinal anesthesia has been initiated, but before the surgery commences. The block will be completed using an aseptic technique under dynamic, in-plane US guidance. 20 mL of injectate consisting of 100mg of ropivicaine and 50 mcg of epinephrine will be injected around the hyperechoic saphenous nerve.
干预措施: Adductor Canal Block (Procedure)
Periarticular Injection + Adductor Canal Block (Local Anesthestic)
The experimental arm with receive both the periarticular injection and the adductor canal block.
The periarticular injection will be performed by the surgeon and will consist of 100 mL of injectate being distributed in the following manner: 30 mL to the posterior capsule, 10 mL to the medial collateral ligament, 10mL to the lateral collateral ligament (ensuring not to infiltrate common peroneal nerve), 20mL to the quadriceps and anterior capsule, and 30 mL to the subcutaneous tissue. The periarticular injection will consist of 250 mg of ropivacaine, 30 mg of ketorolac, and 0.5 mg of epinephrine.
The adductor canal block will be completed by the anesthesiologist after spinal anesthesia has been initiated, but before the surgery commences. The block will be completed using an aseptic technique under dynamic, in-plane US guidance. 20 mL of injectate consisting of 100mg of ropivicaine and 50 mcg of epinephrine will be injected around the hyperechoic saphenous nerve.
干预措施: Periarticular Injection (Procedure)
Periarticular Injection + Adductor Canal Block (Normal Saline)
The control arm with receive a periarticular injection and a sham adductor canal block.
The periarticular injection will be carried out in the same manner as described for the experimental group. The technical aspects of the sham adductor canal block will be the same as for the experimental arm; however, the injectate will consist of 20 mL of normal saline.
干预措施: Adductor Canal Block (Procedure)
Periarticular Injection + Adductor Canal Block (Normal Saline)
The control arm with receive a periarticular injection and a sham adductor canal block.
The periarticular injection will be carried out in the same manner as described for the experimental group. The technical aspects of the sham adductor canal block will be the same as for the experimental arm; however, the injectate will consist of 20 mL of normal saline.
干预措施: Periarticular Injection (Procedure)
结局指标
主要结局
Scoring on the Quality of Recovery-15 Survey
时间窗: Up to 4 weeks post-operatively.
The Quality of Recovery-15 Survey is a validated patient-reported outcome questionnaire that measures the quality of recovery after surgery and anaesthesia. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery). To be completed pre-operatively, and on POD#1, POD#10, and POD#28.
Feasibility Outcomes
时间窗: End of project
Defined by eligibility, recruitment rate, adherence to intervention protocol, percentage of completed outcome measures, participant retention
次要结局
- Postoperative Pain(Throughout hospital stay, an average of 1-2 days.)
- Range of Motion(Throughout hospital stay, an average of 1-2 days.)
- Time to Meet Discharge Criteria(Throughout hospital stay, an average of 1-2 days.)
- Narcotic Consumption(Up to 4 weeks post-operatively.)
- Timed Up and Go (TUG) Test(Throughout hospital stay, an average of 1-2 days.)
研究者
Kim Wong
Principal Investigator
Northern Ontario School of Medicine