A Comparison of Analgesic Efficacy of Ultrasound-guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Opioid Consumption at 24 Hours Post-op
研究概览
简要总结
This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement.
详细描述
Part of the way in which pain is controlled during total knee replacement surgery is through a nerve block. The investigators have developed an effective protocol for pain control after knee replacement, but know that many patients still experience pain around the knee after knee replacement. There are nerves around the knee that carry pain impulses from behind the knee. The investigators believe that placing numbing medicine around these nerves can help with pain in front of the knee after surgery, in addition to the standard nerve block placed for knee replacement surgery. This may result in taking less pain medication by mouth,and having less pain with movement. For this study, before the operation, either a placebo solution or the local anesthetic bupivacaine (a numbing solution) will be placed at three sites around the knee where these nerves reside. The investigators will evaluate how participants feel in recovery after surgery, during the stay in the hospital, and call at home one week after surgery. Knowing if numbing these nerves helps with pain after surgery will help us further refine our postoperative care plan for patients.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled for primary elective total knee arthroplasty
- •American Society of Anesthesiologists Physical Status I-III
- •BMI 18-40 kg/m2
排除标准
- •Inability to cooperate with protocol
- •Inability to understand or speak English
- •Allergy to ropivacaine, bupivacaine or other local anesthetic
- •Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
- •Revision knee surgery
- •Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four weeks prior to surgery)
- •History of chronic pain
- •History of psychiatric disorder
- •History of diabetes mellitus
研究组 & 干预措施
Genicular nerve block with bupivacaine
The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.
干预措施: 15mL 0.25% bupivacaine (Drug)
Genicular nerve block with bupivacaine
The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.
干预措施: Genicular nerve block (Procedure)
Genicular nerve block with saline
The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane (in-plane approach). Once satisfactory position of the needle time is confirmed, 5mL of a saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.
干预措施: Genicular nerve block (Procedure)
Genicular nerve block with saline
The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane (in-plane approach). Once satisfactory position of the needle time is confirmed, 5mL of a saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.
干预措施: Saline (Drug)
结局指标
主要结局
Opioid Consumption at 24 Hours Post-op
时间窗: 24 hours after operation
Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.
次要结局
- Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1(Postoperative day 1)
- Opioid Consumption on Postoperative Day 7(Postoperative day 7)
- Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night(Postoperative day 1)
- Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1(Postoperative Day 1)
- Total Opioid Consumption Through 48 Hours(48 hours)
- Worst Pain Rating Score (NRS-11) on Postoperative Day 7(Postoperative day 7)
- Patient Satisfaction With Pain Control at 24 h(24 hours)
- Patient Satisfaction With Pain Control on Postoperative Day 7(Postoperative day 7)
- 20 Meter Walk Test Time Performed on Postoperative Day 1(On postoperative day 1)