Effectiveness of Preoperative iPACK on Postoperative Pain From Hamstring Autograft for ACL Repair
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Median Post Anesthesia Recovery Unit (PACU) Pain Score
研究概览
简要总结
Patients undergoing ACL repair with hamstring autograft frequently develop significant post operative pain at the hamstring grafting site. This pain is within the distribution of a commonly used regional nerve block, the Interspace between the popliteal artery and capsule of the knee (iPACK). The investigators plan to randomize consenting patients to either receiving a SHAM injection of normal saline or to an interventional group of long acting local anesthetic (Ropivacaine) injected in the popliteal fossa between the popliteal artery and capsule of the knee (iPACK). Both groups of patients will receive standard of care with respect to perioperative pain management, which includes a preoperative adductor canal nerve block and preoperative acetaminophen administration. Dual primary endpoints of postoperative pain scores and mean postoperative opioid use will be retrieved and compared between groups. Additional secondary endpoints will be PACU length of stay, PACU opioid use, POD1 opioids use, and POD1 pain scores (best, worst, average).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The patient will not know which group they are in as they will be injected with either SHAM or Intervention group, which the pharmacy will create. As a result, the anesthesiologist performing the injection and the intraoperative anesthesiologist will also not know if the patient received a SHAM or intervention injection. This will also apply to the PACU nurse. The person performing the data analysis will know which patients received the intervention, as this is required for data analysis.
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
- •Undergoing ACL surgery with expected Hamstring Autograft by Dr. Catherine Robertson at UC San Diego
- •At least 18 years of age
- •Able to Provide Consent in English prior to Surgery
排除标准
- •Pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year)
- •Inability to communicate with the investigators and hospital staff
- •Severe renal, hepatic or cardiac disease
- •Chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone)
- •BMI > 45 kg/m2
- •Allergy to study medications (lidocaine, bupivacaine)
- •Incarceration.
研究组 & 干预措施
Ropivacaine iPACK
Patient will receive standard of care for perioperative pain management. In addition, they will receive a single preoperative injection of 20cc of 0.25% Ropivacaine with 1:400,000 epinephrine in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK).
干预措施: Ropivacaine iPACK Injection (Procedure)
Normal Saline iPACK
Patient will receive standard of care for perioperative pain management. In addition, they will receive a single preoperative injection of 20cc of 0.9% Normal Saline in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK).
干预措施: Normal Saline iPACK Injection (Procedure)
结局指标
主要结局
Median Post Anesthesia Recovery Unit (PACU) Pain Score
时间窗: From arrival in PACU until patient has been cleared for PACU discharge
Median pain score collected in the PACU following surgery on a scale of 1-10 (1 being no pain, 10 being the worst pain the patient has ever experienced)
Total Perioperative Opioid Use (Morphine equivalents)
时间窗: From time of the start of surgery until time that patient meets PACU discharge criteria
Intraoperative and Post Operative (in the PACU) opioid use
次要结局
- PACU Length of Stay (days)(From PACU arrival until criteria for PACU discharge are met)
- PACU Opioid Use (Morphine equivalents)(From PACU arrival until criteria for PACU discharge are met)
- Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents)(Time of discharge from PACU until 24 hours after PACU discharge)
- Best, Worst, Average Pain Scores on POD 1(For the entire length of post operative day 1)
研究者
Brenton Alexander
Associate Physician
University of California, San Diego