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

Primary Purpose

Pain, Postoperative, ACL Injury, Anesthesia, Local

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ropivacaine iPACK Injection
Normal Saline iPACK Injection
Sponsored by
Brenton Alexander
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Ropivacaine iPACK

    Normal Saline iPACK

    Arm 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).

    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).

    Outcomes

    Primary Outcome Measures

    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)
    Total Perioperative Opioid Use (Morphine equivalents)
    Intraoperative and Post Operative (in the PACU) opioid use

    Secondary Outcome Measures

    PACU Length of Stay (days)
    Length of stay from PACU arrival to "ready for discharge" criteria are met
    PACU Opioid Use (Morphine equivalents)
    All opioid use in the PACU
    Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents)
    All Opioid use in the approximate 24 hours following 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)

    Full Information

    First Posted
    September 7, 2021
    Last Updated
    October 4, 2021
    Sponsor
    Brenton Alexander
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05080348
    Brief Title
    Effectiveness of iPACK on Postoperative Pain From Hamstring Autograft Following ACL Repair
    Official Title
    Effectiveness of Preoperative iPACK on Postoperative Pain From Hamstring Autograft for ACL Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    May 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Brenton Alexander

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, ACL Injury, Anesthesia, Local, Opioid Use

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized double blind placebo controlled
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ropivacaine iPACK
    Arm Type
    Active Comparator
    Arm 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).
    Arm Title
    Normal Saline iPACK
    Arm Type
    Sham Comparator
    Arm 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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Ropivacaine iPACK Injection
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Normal Saline iPACK Injection
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Median Post Anesthesia Recovery Unit (PACU) Pain Score
    Description
    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)
    Time Frame
    From arrival in PACU until patient has been cleared for PACU discharge
    Title
    Total Perioperative Opioid Use (Morphine equivalents)
    Description
    Intraoperative and Post Operative (in the PACU) opioid use
    Time Frame
    From time of the start of surgery until time that patient meets PACU discharge criteria
    Secondary Outcome Measure Information:
    Title
    PACU Length of Stay (days)
    Description
    Length of stay from PACU arrival to "ready for discharge" criteria are met
    Time Frame
    From PACU arrival until criteria for PACU discharge are met
    Title
    PACU Opioid Use (Morphine equivalents)
    Description
    All opioid use in the PACU
    Time Frame
    From PACU arrival until criteria for PACU discharge are met
    Title
    Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents)
    Description
    All Opioid use in the approximate 24 hours following PACU Discharge
    Time Frame
    Time of discharge from PACU until 24 hours after PACU discharge
    Title
    Best, Worst, Average Pain Scores on POD 1
    Description
    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)
    Time Frame
    For the entire length of post operative day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brenton Alexander, MD
    Phone
    (858) 657-7000
    Email
    bsalexander@health.ucsd.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rodney Gabriel, MD, MAS
    Phone
    (858) 657-7000
    Email
    ragabriel@ucsd.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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