Clinical trial NCT06561035: ACL-R Opioid Sparing Study
Official title: Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Campbell Clinic
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 56
Sex: ALL
Minimum age (years): 14
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (Shah et al., 2019). 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 (Volkow et al., 2011), 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 (Gazendam et al., 2022; Jones et al., 2022). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 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.
measure: Oral morphine equivalent
timeFrame: 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.
Secondary outcomes:
measure: Incidence of treatment-emergent adverse event.
timeFrame: From day of surgery to 12-week follow up visit.
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: Campbell Clinic
name: Joseph Lamplot, MD
role: PRINCIPAL_INVESTIGATOR
References: