ACL TearNCT06340932
Impact of Opioid Avoidance Protocol for ACL Reconstruction
An observational study of ACL Tear and Post Operative Pain, run by Matthew Varacallo at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- ACL Tear, Post Operative Pain
- What is being tested?
- Iovera, Celecoxib and Acetaminophen
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2024to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adolescents (15 years of age or older) or Adults undergoing primary ACL reconstruction with or without meniscal repair.
Who may be able to join
- Patients aged 15 years or older at screening.
- Primary diagnosis of ACL injury as evidenced by MRI or similar imaging study and are scheduled to undergo ACLR with or without meniscal repair/meniscectomy
- Non-pregnant patients with verbal confirmation that they are not planning to become pregnant during the study period.
- 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.
- English speaking patients
- Provision of informed consent with ability to adhere to the study visit schedule and complete all study assessments.
Who cannot join
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications
- History of contralateral ACL repair within 1 year of screening
- Multi-ligament injury requiring reconstruction
- Inability to return to the study doctor's clinic for postoperative visits
- Pregnant or trying to become pregnant
- Breastfeeding
Show all 14Show fewer
- Have a severe chronic pain condition that in the opinion of the study doctor may impact post-surgical outcomes of analgesic and opioid usage (i.e., fibromyalgia, cancer, sickle cell disease)
- Have a known contraindication to the iovera° device, including any of the following:
- 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:
- Mood disorder (for example, major depression, bipolar) ii. Psychotic disorder (for example, schizophrenia)
- Have a history, suspicion, or clinical manifestation of:
- 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)
- Pregnant or planning to become pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Opioid Avoidance Protocol for ACL Reconstruction Surgery
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.
Read more
Secondary objectives are to:
- evaluate the effects of an opioid avoidance protocol on the daily average numeric rating scale (NRS) pain scores from POD0-7
- evaluate the effects of an opioid avoidance protocol on the daily worst NRS pain score from POD0-7
- evaluate the ability to recover opioid free through 7, 30, and 60 days
- evaluate the quality of recovery 15 (QoR-15) scores on POD2
- assess the number of opioid prescriptions required by patients in the 60 day recover period
- assess Knee Injury and Osteoarthritis Outcome Score (KOOS) pain and symptom scales at 8 weeks post-operatively between groups.
- Conditions
- ACL Tear, Post Operative Pain
- Being tested
- Iovera, Celecoxib, Acetaminophen, Oxycodone, Tramadol
- Keywords
- Iovera, Cryoneurolysis, Multi-modal analgesics
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IoveraDevice
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
CelecoxibDrug
Also called Celebrex
200mg BID
AcetaminophenDrug
Also called Tylenol
1000mg q8h
OxycodoneDrug
As needed
TramadolDrug
As needed
Bupivacaine HydrochlorideDrug
20mL of 0.25% bupivacaine HCl adductor canal block and 15mL of 0.25% bupivacaine HCl (+/- 5mL of normal saline) iPACK
Acetaminophen 500Mg CapDrug
500mg q6h prn
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | 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. Receives: Drug: Oxycodone; Drug: Tramadol; Drug: Bupivacaine Hydrochloride; Drug: Acetaminophen 500Mg Cap | |
| Opioid Avoidance | 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. Receives: Device: Iovera; Drug: Celecoxib; Drug: Acetaminophen; Drug: Oxycodone; Drug: Tramadol; Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption from post-operative day 0 to 7
Total use of opioids in milligrams of morphine equivalent from day 0 through day 7
Measured: 7 days
Secondary outcomes (8)
Average daily pain score via numeric rating scale (NRS)
Average daily pain each day from POD0-7
Measured: 7 Days
Average daily worst pain score via NRS
Average of highest pain scores daily
Measured: 7 days
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Score
Pain subscale of the KOOS questionnaire
Measured: Week 8
Quality of Recovery-15
QoR15 score on POD2
Measured: Day 2
Pittsburgh Rehabilitation Participation Scale Score
Ability to participate in physical therapy weekly
Measured: 8 weeks
KOOS symptom subscale score
Symptom subscale of the KOOS questionnaire
Measured: Week 8
Quantity of opioid prescriptions utilized at day 30 and 60
Number of opioid prescriptions filled by patient at day 30 and 60
Measured: 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
Measured: Days 7, 30, and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start27 Apr 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Varacallo
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor-investigator, Matthew Varacallo, Penn Highlands Hospital Duboia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340932
- Sponsor's protocol ID
- CRS-119 (Pro00077191)
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Opioid Avoidance Protocol for ACL Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT06340932
- Acronym / sponsor ID
- CRS-119 (Pro00077191)
- Conditions
- ACL Tear, Post Operative Pain
- Keywords
- Iovera, Cryoneurolysis, Multi-modal analgesics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Matthew VaracalloUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- evaluate the effects of an opioid avoidance protocol on the daily average numeric rating scale (NRS) pain scores from POD0-7
- evaluate the effects of an opioid avoidance protocol on the daily worst NRS pain score from POD0-7
- evaluate the ability to recover opioid free through 7, 30, and 60 days
- evaluate the quality of recovery 15 (QoR-15) scores on POD2
- assess the number of opioid prescriptions required by patients in the 60 day recover period
- assess Knee Injury and Osteoarthritis Outcome Score (KOOS) pain and symptom scales at 8 weeks post-operatively between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | Drug: Oxycodone, Drug: Tramadol, Drug: Bupivacaine Hydrochloride, Drug: Acetaminophen 500Mg CapTreatment 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. |
| Opioid Avoidance | – | Device: Iovera, Drug: Celecoxib, Drug: Acetaminophen, Drug: Oxycodone, Drug: Tramadol, Drug: Bupivacaine HydrochloridePreoperatively 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescents (15 years of age or older) or Adults undergoing primary ACL reconstruction with or without meniscal repair.
Key inclusion criteria (6 listed)
- Patients aged 15 years or older at screening.
- Primary diagnosis of ACL injury as evidenced by MRI or similar imaging study and are scheduled to undergo ACLR with or without meniscal repair/meniscectomy
- Non-pregnant patients with verbal confirmation that they are not planning to become pregnant during the study period.
- English speaking patients
- Provision of informed consent with ability to adhere to the study visit schedule and complete all study assessments.
Key exclusion criteria (14 listed)
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications
- History of contralateral ACL repair within 1 year of screening
- Multi-ligament injury requiring reconstruction
- Inability to return to the study doctor's clinic for postoperative visits
- Pregnant or trying to become pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IoveraCryoneurolysis 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 | Device | Opioid Avoidance |
| CelecoxibAlso: Celebrex200mg BID | Drug | Opioid Avoidance |
| AcetaminophenAlso: Tylenol1000mg q8h | Drug | Opioid Avoidance |
| OxycodoneAs needed | Drug | Opioid Avoidance, Standard of Care |
| TramadolAs needed | Drug | Opioid Avoidance, Standard of Care |
| Bupivacaine Hydrochloride20mL of 0.25% bupivacaine HCl adductor canal block and 15mL of 0.25% bupivacaine HCl (+/- 5mL of normal saline) iPACK | Drug | Opioid Avoidance, Standard of Care |
| Acetaminophen 500Mg Cap500mg q6h prn | Drug | Standard of Care |
Primary outcome
Opioid consumption from post-operative day 0 to 7
Time frame: 7 days
Total use of opioids in milligrams of morphine equivalent from day 0 through day 7
8 secondary outcomes
Average daily pain score via numeric rating scale (NRS)
Time frame: 7 Days
Average daily worst pain score via NRS
Time frame: 7 days
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Score
Time frame: Week 8
Quality of Recovery-15
Time frame: Day 2
Pittsburgh Rehabilitation Participation Scale Score
Time frame: 8 weeks
KOOS symptom subscale score
Time frame: Week 8
Quantity of opioid prescriptions utilized at day 30 and 60
Time frame: Day 30 and Day 60
Opioid-free at day 7, day 30, and day 60
Time frame: Days 7, 30, and 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Tear and Post Operative Pain, run by Matthew Varacallo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption from post-operative day 0 to 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.