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

NCT05080348 | Unknown DMC

• 1 other identifier: iPACK ACL Hamstring Autograft
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

Ropivacaine iPACK

ACTIVE COMPARATOR

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

Normal Saline iPACK

SHAM COMPARATOR

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

Interventions

Ropivacaine iPACK Injection PROCEDURE

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

Ropivacaine iPACK

Normal Saline iPACK Injection PROCEDURE

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

Normal Saline iPACK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brenton Alexander: lead

MeSH Terms

Conditions

Pain, Postoperative; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Knee Injuries; Leg Injuries; Wounds and Injuries

Central Study Contacts

Brenton Alexander, MD

CONTACT

(858) 657-7000; bsalexander@health.ucsd.edu

Rodney Gabriel, MD, MAS

CONTACT

(858) 657-7000; ragabriel@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Physician

Model Details: Randomized double blind placebo controlled

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 15, 2021
• Study Start: December 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share