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IPACK on Early Pain Scores After ACL Reconstruction

Primary Purpose

Pain, Postoperative, Anterior Cruciate Ligament Injuries, Analgesics, Opioid

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IPACK
PLACEBO
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients presenting to Dr. John Miller with the Department of Orthopedic Surgery, Sports Medicine Division, at Loyola University Medical Center electing to undergo ACL reconstruction surgery. Patients 16 and over English speaking patients Patients who have the capacity to make their own medical decisions and consent to the study Exclusion Criteria: Previous surgery on the operative knee Previous knee infection Chronic opioid use Have a known allergy to local anesthetics Patient using autograft (cadaver) for ACL reconstruction.

Sites / Locations

  • Loyola University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IPACK

Placebo

Arm Description

After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of 0.5% bupivacaine will be injected.

After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of normal saline will be injected.

Outcomes

Primary Outcome Measures

Pain Scores
Visual Analogue Scale (VAS). Participants self-report their post surgical pain from a scale of 0 to 10.
Opioid Consumption
Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2023
Last Updated
August 3, 2023
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT05985629
Brief Title
IPACK on Early Pain Scores After ACL Reconstruction
Official Title
The Effect of IPACK Nerve Blocks on Early ACL Pain Scores
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2023 (Actual)
Primary Completion Date
August 3, 2025 (Anticipated)
Study Completion Date
August 3, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to learn whether using an anesthetic technique called IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to answer are: if participants who receive the IPACK block prior to ACL reconstruction experience less pain after surgery and at 1 day after surgery if participants who receive the IPACK block prior to ACL reconstruction require less short-term opioid use immediately after surgery and up to one week after surgery. Participants will be randomized 1:1 to 1 of 2 groups: Use of IPACK block during ACL reconstruction vs. placebo (a placebo is a look-alike substance that contains no active drug). Neither the participant nor the investigator will know which group the participants has been assigned to. Researchers will compare self-reported pain scores and short-term opioid use of all study participants.
Detailed Description
Eligible patients will be approached for voluntary study participation after they have made the decision to pursue an elective ACL reconstruction surgery with Dr. John Miller of Loyola University Department of Orthopedic Surgery for management of their ACL tear. The study design is a double-blind, randomized trial. Patients will be randomly selected to the control group or the treatment group. The groups will be randomized 1:1 using a block method to be implemented. The control group will receive a sham block, while the treatment group will receive the IPACK block. The use of a sham block, administered by the anesthesia team, is to ensure that Dr. Miller is blinded to patient's treatment group. After administration of the block and a completed ACL reconstruction surgery, pain scores will be collected from the patient at two time points. First, pain scores will be collected in the post-anesthesia care (PACU) unit using the visual analogue scale (VAS) immediately upon waking up, one hour after waking up and upon discharge. Second, pain scores will be collected during the standard post-operative follow-up phone call that Dr. Miller makes with all his patients one day after surgery using the VAS pain scale. Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery using a simple questionnaire

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anterior Cruciate Ligament Injuries, Analgesics, Opioid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
An unblinded pharmacist will prepare the study drugs consisting of IPACK block, or the sham block consisting of saline (control group). All patients will be premedicated with midazolam, which is standard of care prior to general anesthesia. The use of a sham block, administered by the anesthesia team, is to ensure that the Investigator is blinded to patient's treatment group.
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPACK
Arm Type
Experimental
Arm Description
After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of 0.5% bupivacaine will be injected.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of normal saline will be injected.
Intervention Type
Drug
Intervention Name(s)
IPACK
Intervention Description
Infiltration between the popliteal artery and capsules of the knee (IPACK) is a novel ultrasound-guided technique that provides additional regional analgesic relief to the posterior aspect of the knee without complications seen in a sciatic nerve block. The intention of the IPACK block is to anesthetize the terminal sensory nerves while sparing the main trucks of the common peroneal and tibial nerves.
Intervention Type
Drug
Intervention Name(s)
PLACEBO
Intervention Description
The control group will receive the normal pre-procedure care including a pre-operative visit, surgery, and post-operative care. The control group will receive a sham block consisting of saline in the same anatomical location and manner that the intervention IPACK block is administered.
Primary Outcome Measure Information:
Title
Pain Scores
Description
Visual Analogue Scale (VAS). Participants self-report their post surgical pain from a scale of 0 to 10.
Time Frame
Immediately after surgery; 1 hour, 2-3 hours, and 24 hours after surgery
Title
Opioid Consumption
Description
Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery.
Time Frame
2-3 hours after surgery; 1 week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients presenting to Dr. John Miller with the Department of Orthopedic Surgery, Sports Medicine Division, at Loyola University Medical Center electing to undergo ACL reconstruction surgery. Patients 16 and over English speaking patients Patients who have the capacity to make their own medical decisions and consent to the study Exclusion Criteria: Previous surgery on the operative knee Previous knee infection Chronic opioid use Have a known allergy to local anesthetics Patient using autograft (cadaver) for ACL reconstruction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Miller, MD
Phone
708-216-8730
Email
johnmiller@lumc.edu
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Fargo, BA, CIP, CCRP
Phone
708-216-8046
Email
sfargo@luc.edu
First Name & Middle Initial & Last Name & Degree
John Miller, MD
First Name & Middle Initial & Last Name & Degree
Scott Byram, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We do not have intentions on sharing IPD with other researchers at this time. If we decide to collaborate in the future, IPD will be de-identified prior to sharing.
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://hsd.luc.edu/cro/
Available IPD/Information Comments
Information about this study can be requested from the Clinical Research Office at Loyola University Chicago by calling 708-216-1153 or by mail at: Loyola University Chicago Center for Translational Research and Education (CTRE) Bldg. 115, Suite 253, Rm 255 Maywood, IL 60153

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IPACK on Early Pain Scores After ACL Reconstruction

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