Anterior Cruciate Ligament Rupture Clinical Trial
Official title:
Pain Management of Anterior Cruciate Ligament Reconstruction: Evaluation of Adductor Canal Block Versus Oral Pain Regimen
Verified date | May 2024 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare the outcome of pain interventions that are considered standard of care during the surgical treatment of ACL injuries. The comparison will be looking at pain control during and after ACL surgery as well as functional outcomes in patients that had a nerve block versus those who did not. The investigators hypothesize that pain control will be equal between both groups.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Between the ages of 18 and 45 years old. - Clinical and/or advanced imaging confirmation of ACL tear of which reconstructive surgery is recommended and accepted. Exclusion Criteria: - No prior surgery of the affected and contralateral knee - Adults unable to consent - Children (age < 18 years old) - Prisoners - Pregnant women - Inflammatory arthritis - Non-English-speaking patients |
Country | Name | City | State |
---|---|---|---|
United States | UC Davis Health | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Abdallah FW, Whelan DB, Chan VW, Prasad GA, Endersby RV, Theodoropolous J, Oldfield S, Oh J, Brull R. Adductor Canal Block Provides Noninferior Analgesia and Superior Quadriceps Strength Compared with Femoral Nerve Block in Anterior Cruciate Ligament Reconstruction. Anesthesiology. 2016 May;124(5):1053-64. doi: 10.1097/ALN.0000000000001045. — View Citation
Aronowitz ER, Kleinbart FA. Outpatient ACL reconstruction using intraoperative local analgesia and oral postoperative pain medication. Orthopedics. 1998 Jul;21(7):781-4. doi: 10.3928/0147-7447-19980701-07. — View Citation
Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immediate Post-op Pain Score | Measured via Visual Analog Scale (VAS) in recovery, scale from 0 (least) to 10 (maximum), no units, with 0 being no pain and 10 being extreme pain | 15 min post-op | |
Primary | Opioid Use | Aggregated amount of narcotic medication used, measured in milligrams | 6 weeks post-op | |
Secondary | Short-term Knee Function Post-op | Functional recovery of knee following surgery as measured by Knee Injury and Osteoarthritis Outcome Score (no units), range from 0 - 100 with 0 representing extreme problems with the knee and 100 representing no problems | 6 weeks post-op | |
Secondary | Intermediate-term Knee Function | Functional recovery of knee following surgery as measured by Marx activity score (no unit), 0 - 16, with 0 representing significant limitation in activity due to knee and 16 representing no limitations | 12 weeks post-op | |
Secondary | Long-term Knee Function | Functional recovery of knee following surgery as measured by Tegner activity score (no units), range from 0 - 10, with 0 representing inability to work or perform daily activities due to knee and 10 representing ability to compete in high-level activities | 24 weeks post-op | |
Secondary | Post-anaesthesia care unit (PACU) Time | Amount of time, measured in minutes, participants required in PACU before discharge due to pain control | Immediately after surgery |
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