protocolSection identificationModule nctId: NCT06340932, orgStudyIdInfo id: CRS-119 (Pro00077191), briefTitle: Impact of Opioid Avoidance Protocol for ACL Reconstruction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Matthew Varacallo, class: OTHER, collaborators name: Pacira Biosciences, descriptionModule briefSummary: 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 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 MME from POD0-7 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 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 QoR-15 scores on POD2* assess the number of opioid prescriptions required by patients in the 60 day recover period* assess KOOS pain and symptom scales at 8 weeks post-operatively between groups., conditionsModule conditions: ACL Tear, conditions: Post Operative Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Iovera, interventions name: Celecoxib, interventions name: Acetaminophen, interventions name: Oxycodone, interventions name: Tramadol, interventions name: Bupivacaine Hydrochloride, interventions name: Acetaminophen 500Mg Cap, outcomesModule primaryOutcomes measure: Opioid consumption from POD0-POD7, secondaryOutcomes measure: Average daily pain (NRS), secondaryOutcomes measure: Average daily worst pain (NRS), secondaryOutcomes measure: KOOS Pain Subscale Score, secondaryOutcomes measure: Quality of Recovery-15, secondaryOutcomes measure: Pittsburgh Rehabilitation Participation Scale Score, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Penn Highlands Dubois, city: DuBois, state: Pennsylvania, zip: 15801, country: United States, contacts name: Samantha Morgan, DAT, role: CONTACT, phone: 814-496-3141, email: slmorgan@phhealthcare.org, contacts name: Christopher Varacallo, role: SUB_INVESTIGATOR, contacts name: Samantha Morgan, role: SUB_INVESTIGATOR, geoPoint lat: 41.11923, lon: -78.76003, hasResults: False