Clinical trial NCT06340932: Impact of Opioid Avoidance Protocol for ACL Reconstruction
Official title: Impact of Opioid Avoidance Protocol for ACL Reconstruction Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL Tear
Post Operative Pain
Keywords: Iovera
Cryoneurolysis
Multi-modal analgesics
Lead sponsor: Penn Highlands Hospital Duboia
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2024-04-02
Enrollment: 32
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents (15 years of age or older) or Adults undergoing primary ACL reconstruction with or without meniscal repair.

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.


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

Primary outcomes:
measure: Opioid consumption from post-operative day 0 to 7
timeFrame: 7 days
Secondary outcomes:
measure: Average daily pain score via numeric rating scale (NRS)
timeFrame: 7 Days
measure: Average daily worst pain score via NRS
timeFrame: 7 days
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscale Score
timeFrame: Week 8
measure: Quality of Recovery-15
timeFrame: Day 2
measure: Pittsburgh Rehabilitation Participation Scale Score
timeFrame: 8 weeks
measure: KOOS symptom subscale score
timeFrame: Week 8
measure: Quantity of opioid prescriptions utilized at day 30 and 60
timeFrame: Day 30 and Day 60
measure: Opioid-free at day 7, day 30, and day 60
timeFrame: Days 7, 30, and 60
Other outcomes:
Locations:
city: DuBois
country: United States
facility: Penn Highlands Dubois
state: Pennsylvania
Study officials:
References: