Impact of Opioid Avoidance Protocol for ACL Reconstruction

Post Operative Pain Clinical Trial

Official title:

Impact of Opioid Avoidance Protocol for ACL Reconstruction Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06340932
• Other study ID #: CRS-119 (Pro00077191)
• Status: Not yet recruiting
• Start date: March 28, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2024
• Source: Penn Highlands Hospital Duboia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 1, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACL Tear
• Pain, Postoperative
• Post Operative Pain

Intervention

Device:
• 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

Drug:
• Celecoxib
200mg BID
• Acetaminophen
1000mg q8h
• Oxycodone
As needed
• Tramadol
As needed
• Bupivacaine Hydrochloride
20mL of 0.25% bupivacaine HCl adductor canal block and 15mL of 0.25% bupivacaine HCl (+/- 5mL of normal saline) iPACK
• Acetaminophen 500Mg Cap
500mg q6h prn

Locations

Country	Name	City	State
United States	Penn Highlands Dubois	DuBois	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Matthew Varacallo	Pacira Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption from POD0-POD7	Total use of opioids in milligrams of morphine equivalent from day 0 through day 7	7 days
Secondary	Average daily pain (NRS)	Average daily pain each day from POD0-7	7 Days
Secondary	Average daily worst pain (NRS)	Average of highest pain scores daily	7 days
Secondary	KOOS Pain Subscale Score	Pain subscale of the KOOS questionnaire	Week 8
Secondary	Quality of Recovery-15	QoR15 score on POD2	Day 2
Secondary	Pittsburgh Rehabilitation Participation Scale Score	Ability to participate in physical therapy weekly	8 weeks