An observational study in ACL Tear and Post Operative Pain, sponsored by Matthew Varacallo. Completed at 1 site in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Matthew Varacallo · Observational
This is a prospective, quasi-experimental, cohort study comparing patients treated with one of two postoperative pain management protocols. The two protocols assessed will be the current standard of care protocol for Anterior Cruciate Ligament Reconstruction (ACLR) postoperative pain control utilized by Dr. Matthew Varacallo and then an opioid avoidance protocol that is planned to be implemented on the Spring of 2024. The study is voluntary, however all patients will be treated with either of the two protocols depending on their date of surgery. This study will include patients aged 15 years and older who consent to the participation in the study. Patients will be identified utilizing the operative surgeon's appointment calendar and will be screened and offered inclusion in the study if applicable at their pre-operative visit. Data will be collected via patient medication and pain diary, phone call, and clinician administration of standardized outcome questionnaires. Patients will be included in the standard of care group if ACLR is performed prior to the change in protocol in the Spring of 2024 or the opioid avoidance group if performed after the protocol change.
The primary objective of this study is to evaluate the effect of the opioid avoidance protocol on opioid use in milligrams of morphine equivalent (MME) from postoperative day (POD) 0 to 7 after ACLR compared to the current standard of care pain management protocol.
Secondary objectives are to:
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 32 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Matthew Varacallo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adolescents (15 years of age or older) or Adults undergoing primary ACL reconstruction with or without meniscal repair.
Non-pregnant patients with verbal confirmation that they are not planning to become pregnant during the study period.
i. Female subjects must have a confirmatory negative pregnancy test as part of the routine pre-operative laboratory testing ii. Subjects must endorse a plan to utilize contraceptives (condoms, hormonal birth control, IUD, etc.) for any sexual activity during the study period.
Exclusion Criteria:
Have a known contraindication to the iovera° device, including any of the following:
i. Cryoglobulinemia (presence of abnormal proteins in the blood that thicken in cold temperatures) ii. Paroxysmal cold hemoglobinuria (an autoimmune disorder where cold-reacting antibodies that attack and destroy red blood cells) iii. Cold urticaria (temporary itchy welts [hives] on skin exposed to cold temperatures) iv. Raynaud's disease (which causes some areas of the body, such as fingers and toes, to feel numb and cold in response to cold temperatures) v. Open and/or infected wounds at or near the study treatment site vi. Coagulopathy (problems with blood clotting)
Have poorly controlled mental illness that in the opinion of the study doctor may meaningfully impact study treatment outcomes, including any of the following:
i. Mood disorder (for example, major depression, bipolar) ii. Psychotic disorder (for example, schizophrenia)
Have a history, suspicion, or clinical manifestation of:
i. Alcohol abuse or dependence ii. Illicit drug use iii. Opioid abuse or dependence (greater than or equal to 40 mg morphine equivalent dose by mouth per day in the past 30 days)
Treatment of pain as per standard of care. Patients will receive regional anesthesia blocks, acetaminophen, and as needed opioids; tramadol and oxycodone postoperatively for pain management.
Drug: Oxycodone · Drug: Tramadol · Drug: Bupivacaine Hydrochloride · Drug: Acetaminophen 500Mg Cap
Preoperatively patients will receive cryoneurolysis of 5 sensory nerves that innervate the knee 7 to 21 days before surgery. Patients will receive perioperative NSAIDs and acetaminophen along with regional anesthesia. For postoperative pain control patients will receive scheduled acetaminophen and NSAIDs and may request opioids as needed.
Device: Iovera · Drug: Celecoxib · Drug: Acetaminophen · Drug: Oxycodone · Drug: Tramadol · Drug: Bupivacaine Hydrochloride
Cryoneurolysis of 5 sensory nerves (Intermediate branch of the AFCN, Medial Femoral Cutaneous Nerve, Suprapatellar branch of the saphenous nerve, 2 branches of the infrapatellar branch of the saphenous nerve) causing Wallerian degeneration
200mg BID
Also known as: Celebrex
1000mg q8h
Also known as: Tylenol
As needed
As needed
20mL of 0.25% bupivacaine HCl adductor canal block and 15mL of 0.25% bupivacaine HCl (+/- 5mL of normal saline) iPACK
500mg q6h prn
Opioid consumption from post-operative day 0 to 7
Total use of opioids in milligrams of morphine equivalent from day 0 through day 7
Time frame: 7 days
Average daily pain score via numeric rating scale (NRS)
Average daily pain each day from POD0-7
Time frame: 7 Days
Average daily worst pain score via NRS
Average of highest pain scores daily
Time frame: 7 days
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Score
Pain subscale of the KOOS questionnaire
Time frame: Week 8
Quality of Recovery-15
QoR15 score on POD2
Time frame: Day 2
Pittsburgh Rehabilitation Participation Scale Score
Ability to participate in physical therapy weekly
Time frame: 8 weeks
KOOS symptom subscale score
Symptom subscale of the KOOS questionnaire
Time frame: Week 8
Quantity of opioid prescriptions utilized at day 30 and 60
Number of opioid prescriptions filled by patient at day 30 and 60
Time frame: Day 30 and Day 60
Opioid-free at day 7, day 30, and day 60
Percentage of patients who did not utilize opioid prescriptions at 3 time points
Time frame: Days 7, 30, and 60
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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