NCT05985629 IPACK on Early Pain Scores After ACL Reconstruction
| NCT ID | NCT05985629 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Loyola University |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2023-08-03 |
| Primary Completion | 2025-08-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 78 participants in total. It began in 2023-08-03 with a primary completion date of 2025-08-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05985629 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05985629 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05985629 currently recruiting?
Yes, NCT05985629 is actively recruiting participants. Contact the research team at johnmiller@lumc.edu for enrollment information.
Where is the NCT05985629 trial being conducted?
This trial is being conducted at Maywood, United States.
Who is sponsoring the NCT05985629 clinical trial?
NCT05985629 is sponsored by Loyola University. The trial plans to enroll 78 participants.