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
About this trial
This is an interventional treatment trial for Pain, Postoperative
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.
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
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
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Effectiveness of iPACK on Postoperative Pain From Hamstring Autograft Following ACL Repair
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