Studying the Effects of iPACK Blocks With Adductor Canal Blocks for Postoperative Analgesia Following ACL Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Pain Scores
研究概览
简要总结
This study will consist of patients 12 years and older undergoing ACL reconstruction using a quadriceps or bone-patella tendon bone (BTB) graft. The patients will be randomized to adductor canal block alone, or adductor canal block + iPACK block. The primary goal will be to determine the differences in postoperative pain during the first 72 hours when comparing the two groups. Secondary outcomes will include opioid utilization during the first 72 hours postoperatively and range of motion including terminal knee extension at postoperative follow-up visits.
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)
盲法说明
Only the patient will be blinded to the treatment group.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 years and older
- •Patients who are scheduled to undergo an ACL reconstruction with quadriceps or BTB graft.
排除标准
- •Any contraindication to receiving regional anesthesia. This may include infection at the site of injection, allergy to local anesthetic, or pre-existing nerve injury.
- •Patients undergoing hamstring graft or allograft for ACL
- •Pre-existing infection at the site of injury
- •Patients on chronic opioid treatments
- •Pre-existing sensory or motor deficit in operative extremity
- •Patients having a revision of previous ACL reconstruction
- •Pregnant and/or lactating women
- •Weighs less than 40kg
研究组 & 干预措施
Adductor Canal Block (ACB) Only
Participants randomized to the ACB only group will receive an adductor canal block alone.
干预措施: Adductor Canal Block (ACB) Only (Drug)
ACB + iPACK
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
干预措施: Adductor Canal Block (ACB) + iPACK Block (Drug)
结局指标
主要结局
Pain Scores
时间窗: 0-72 hours post op
The primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome.
次要结局
- Total Postoperative Opioid Consumption (Total MME)(up to 72 hours post-op)
- Range of Motion (Degrees)(up to two months after surgery)
研究者
Carey Brewbaker
Assistant Professor
Medical University of South Carolina