Status:
ENROLLING_BY_INVITATION
ACL-R Opioid Sparing Study
Lead Sponsor:
Campbell Clinic
Conditions:
Anterior Cruciate Ligament Injuries
Eligibility:
All Genders
14-85 years
Phase:
PHASE3
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 con...
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 ofte...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06561035
Start Date
September 1 2024
End Date
June 1 2026
Last Update
August 19 2024
Active Locations (1)
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1
Campbell Clinic
Memphis, Tennessee, United States, 38138