IPACK on Early Pain Scores After ACL Reconstruction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorLoyola University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous surgery on the operative knee
Previous knee infection
Chronic opioid use
Have a known allergy to local anesthetics
Trial design
Design model
Parallel
Treatments tested in this trial
IPACK
DrugInfiltration 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
DrugThe 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.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: IPACKExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Scores
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 surgery2
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.
Time frame
2-3 hours after surgery; 1 week after surgerySponsors and contacts
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Source ClinicalTrials.gov