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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Anesthesia, Local; Opioid Use; ACL Injury
• Intervention / Treatment: Procedure: Ropivacaine iPACK Injection; Procedure: Normal Saline iPACK Injection

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brenton Alexander, MD; Phone Number: (858) 657-7000; Email: bsalexander@health.ucsd.edu
• Study Contact Backup: Name: Rodney Gabriel, MD, MAS; Phone Number: (858) 657-7000; Email: ragabriel@ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: Ropivacaine iPACK Injection; 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
Sham Comparator: 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).	Procedure: Normal Saline iPACK Injection; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brenton Alexander

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Knee Injuries; Pain, Postoperative; Anterior Cruciate Ligament Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: iPACK ACL Hamstring Autograft

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No