IPACK on Early Pain Scores After ACL Reconstruction

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Loyola University
Study ID
NCT05985629
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IPACK — DRUG
    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.
  • PLACEBO — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 3, 2023
Status verified
Aug 2023
Primary completion
Aug 3, 2025
Completion
Aug 3, 2026

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IPACK
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Pain Scores [ Time Frame: Immediately after surgery; 1 hour, 2-3 hours, and 24 hours after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Loyola University Medical CenterMaywoodIllinois60153
Susan Fargo, BA, CIP, CCRP
[email protected]
708-216-8046
John Miller, MD (PRINCIPAL_INVESTIGATOR)
Scott Byram, MD (SUB_INVESTIGATOR)

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By research site
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