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

Brenton Alexander

Status: Unknown

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

Treatments: Procedure: Ropivacaine iPACK Injection; Procedure: Normal Saline iPACK Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05080348

iPACK ACL Hamstring Autograft

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Ropivacaine iPACK

Active Comparator group

Description:

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).

Treatment:

Procedure: Ropivacaine iPACK Injection

Normal Saline iPACK

Sham Comparator group

Description:

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).

Treatment:

Procedure: Normal Saline iPACK Injection