Campbell Clinic
Memphis, Tennessee, 38138, United States
NCT Number: NCT06561035
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).
Interested in participating?
Request Info14 year–85 year
All sexes
Interventional
Phase 3
Memphis, Tennessee, 38138, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive medications in the Opiate Sparing arm for pain control.
Subjects will receive medications in the Opiate Based arm for pain control.
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.
Record pain score with 0 being no pain at all and 10 being worst pain possible.
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.
Opiate pill count
Time frame: From day of surgery to 12-week follow up visit.
Campbell Clinic
Other
Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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