Anterior Cruciate Ligament Injuries
Conditions
Brief summary
This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).
Detailed description
There is increased attention on opioid prescription patterns and post-operative narcotic consumption in light of the ongoing opioid crisis in the United States. Patients with opioid use disorders often have their first exposure to opioids following a medical or surgical procedure. Approximately 6% of patients who were opioid native preoperatively and received opioids postoperatively became long term users. As orthopedic surgeons account for approximately 8% of all dispensed opioid prescriptions, surgeons have investigated the effectiveness of multimodal analgesic regimens in controlling post-operative pain and reducing the amount of opioid consumption. Recent studies have shown that an opiate sparing regimen consisted of nonsteroidal anti-inflammatory drugs can control post-operative pain adequately while reducing opioid consumption in patients who underwent arthroscopic knee or shoulder surgeries. Currently, there is no clear consensus on pain management regimen after anterior cruciate ligament reconstruction. The purpose of this study is to 1) investigate the difference in pain score and opioid consumption among patients who receive the opioid-based protocol and those who receive opioid-sparing protocol; 2) minimize and potentially eliminate the utilization of narcotics following anterior cruciate ligament reconstruction (ACL-R) surgery.
Interventions
DRUGOpiate Sparing
Subjects will receive medications in the Opiate Sparing arm for pain control.
DRUGOpiate Based
Subjects will receive medications in the Opiate Based arm for pain control.
Sponsors
Campbell Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 14-85 years of age. * Patients undergoing primary ACL-R with or without meniscus repair or meniscectomy, with or without chondroplasty. * Patients weigh at least 90lbs at time of enrollment. * Surgery scheduled at a Campbell Clinic Surgery Center (Midtown or Wolf River). * Willing and able to provide written informed consent. * Willing and able to cooperate with postoperative therapy. * Speak and read fluent English.
Exclusion criteria
* Multiligament knee reconstruction. * Pre-injury opioid consumption. * Substance abuse disorder (illicit drug abuse, alcoholism, etc). * Concomitant injuries or surgeries warranting pain medication (i.e. polytrauma patient). * Chronic pain syndrome. * Renal disease. * Currently taking selective serotonin reuptake inhibitors and/or serotonin and norepinephrine reuptake inhibitors. * Known sensitivity, allergy, or intolerance to medications within protocols. * History of diabetes. * Currently taking glucagon-like peptide 1 agonist. * Female patient who is pregnant on day of surgery or becomes pregnant during study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | Once per day from postoperative day 1 to postoperative day 14; at two weeks follow up visit, 6 weeks follow up visit and 12 weeks follow up visit. | Record pain score with 0 being no pain at all and 10 being worst pain possible. |
| Oral morphine equivalent | daily pill count from postoperative day 1 to postoperative day 14; at 2-week follow up visit, 6-week follow up visit and 12-week follow up visit. | Opiate pill count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse event. | From day of surgery to 12-week follow up visit. | Adverse event occurrence |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFrederick Azar, MD
Campbell Clinic
Outcome results
None listed