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

Not Applicable

• Conditions: Pain, Postoperative; ACL Injury; Anesthesia, Local; Opioid Use
• Interventions: Procedure: Normal Saline iPACK Injection; Procedure: Ropivacaine iPACK Injection

• Registration Number: NCT05080348
• Lead Sponsor: Brenton Alexander

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-07
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-04
• Last Update Submitted: 2021-10-04
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Study Start: 2021-12
• Primary Completion: 2022-04
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline iPACK	Normal Saline iPACK Injection	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).
Ropivacaine iPACK	Ropivacaine iPACK Injection	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).

Primary Outcome Measures

Name	Time	Method
Median Post Anesthesia Recovery Unit (PACU) Pain Score	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)	From time of the start of surgery until time that patient meets PACU discharge criteria	Intraoperative and Post Operative (in the PACU) opioid use

Secondary Outcome Measures

Name	Time	Method
PACU Length of Stay (days)	From PACU arrival until criteria for PACU discharge are met	Length of stay from PACU arrival to "ready for discharge" criteria are met
PACU Opioid Use (Morphine equivalents)	From PACU arrival until criteria for PACU discharge are met	All opioid use in the PACU
Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents)	Time of discharge from PACU until 24 hours after PACU discharge	All Opioid use in the approximate 24 hours following PACU Discharge
Best, Worst, Average Pain Scores on POD 1	For the entire length of post operative day 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)