Effectiveness of iPACK on Postoperative Pain From Hamstring Autograft Following ACL Repair

Study Overview
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Brief Summary
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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).

Official Title
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Effectiveness of Preoperative iPACK on Postoperative Pain From Hamstring Autograft for ACL Repair

Conditions
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Pain, Postoperative, ACL Injury, Anesthesia, Local, Opioid Use

Intervention / Treatment
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* Procedure: Ropivacaine iPACK Injection
* Procedure: Normal Saline iPACK Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized double blind placebo controlled
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine iPACK<br>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). | Procedure: Ropivacaine iPACK Injection<br>* Injection of 20mL of 0.25% Ropivacaine with 1:400,000 Epinephrine between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles<br>|
| Sham Comparator: Normal Saline iPACK<br>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). | Procedure: Normal Saline iPACK Injection<br>* Injection of 20mL of 0.9% Normal Saline between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Post Anesthesia Recovery Unit (PACU) Pain Score | 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) | From arrival in PACU until patient has been cleared for PACU discharge | 
| Total Perioperative Opioid Use (Morphine equivalents) | Intraoperative and Post Operative (in the PACU) opioid use | From time of the start of surgery until time that patient meets PACU discharge criteria | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PACU Length of Stay (days) | Length of stay from PACU arrival to ready for discharge criteria are met | From PACU arrival until criteria for PACU discharge are met | 
| PACU Opioid Use (Morphine equivalents) | All opioid use in the PACU | From PACU arrival until criteria for PACU discharge are met | 
| Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents) | All Opioid use in the approximate 24 hours following PACU Discharge | Time of discharge from PACU until 24 hours after PACU discharge | 
| Best, Worst, Average Pain Scores on POD 1 | Best, Worst and Average pain scores collected on POD 1 following surgery on a scale of 1-10 (1 being no pain, 10 being the worst pain the patient has ever experienced) | For the entire length of post operative day 1 |