Impact of Opioid Avoidance Protocol for ACL Reconstruction

NCT ID: NCT06340932

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-27
• Study Completion Date: 2025-02-01

Brief 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. 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.

Conditions

ACL Tear; Post Operative Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Oxycodone

Intervention Type: DRUG

As needed

Tramadol

Intervention Type: DRUG

As needed

Bupivacaine Hydrochloride

Intervention Type: DRUG

20mL of 0.25% bupivacaine HCl adductor canal block and 15mL of 0.25% bupivacaine HCl (+/- 5mL of normal saline) iPACK

Acetaminophen 500Mg Cap

Intervention Type: DRUG

500mg q6h prn

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.

Iovera

Intervention Type: DEVICE

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

Celecoxib

Intervention Type: DRUG

200mg BID

Acetaminophen

Intervention Type: DRUG

1000mg q8h

Oxycodone

Intervention Type: DRUG

As needed

Tramadol

Intervention Type: DRUG

As needed

Bupivacaine Hydrochloride

Intervention Type: DRUG

20mL of 0.25% bupivacaine HCl adductor canal block and 15mL of 0.25% bupivacaine HCl (+/- 5mL of normal saline) iPACK

Interventions

Iovera

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

Intervention Type: DEVICE

Celecoxib

200mg BID

Intervention Type: DRUG

Acetaminophen

1000mg q8h

Intervention Type: DRUG

Oxycodone

As needed

Intervention Type: DRUG

Tramadol

As needed

Intervention Type: DRUG

Bupivacaine Hydrochloride

20mL of 0.25% bupivacaine HCl adductor canal block and 15mL of 0.25% bupivacaine HCl (+/- 5mL of normal saline) iPACK

Intervention Type: DRUG

Acetaminophen 500Mg Cap

500mg q6h prn

Intervention Type: DRUG

Other Intervention Names

Celebrex; Tylenol

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• English speaking patients
• Provision of informed consent with ability to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria

• 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
• 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:

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)

• Pregnant or planning to become pregnant during the study period

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Matthew Varacallo

OTHER

Sponsor Role: lead

Responsible Party

Matthew Varacallo

Orthopedic Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Penn Highlands Dubois

DuBois, Pennsylvania, United States

Countries

United States

Other Identifiers

CRS-119 (Pro00077191)

Identifier Type: -

Identifier Source: org_study_id