ACL-R Opioid Sparing Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opiate Sparing, Opiate Based.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament Injuries. Basic parameters: 14 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery
Overview
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.
Interventions
- Drug Opiate Sparing
Subjects will receive medications in the Opiate Sparing arm for pain control. - Drug Opiate Based
Subjects will receive medications in the Opiate Based arm for pain control.
Primary outcome measures
- Visual Analog Scale [Time frame: 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.]
- Oral morphine equivalent [Time frame: 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 outcome measures (1)
- Incidence of treatment-emergent adverse event. [Time frame: From day of surgery to 12-week follow up visit.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Campbell Clinic — Memphis
Identifiers
NCT: NCT06561035 · 24-09976-FB