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Trial Evaluating Postop Pain and Muscle Strength Among Regional Anesthesia Techniques for Ambulatory ACL Reconstruction
N/A
Waitlist Available
Led By Christopher Sobey, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post operative week 6
Awards & highlights
Approved for 60 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
Despite the apparent multifaceted benefit in differentiating blockade sites and duration of nerve blockade, the efficacy of continuous adductor canal blockade utilized specifically in ACL reconstruction has not been extensively studied. This study will test the hypothesis that the use of the adductor canal continuous nerve catheter will result in lower subjective pain scores on postoperative day 2 and improved quadriceps strength on postoperative day 1.
Eligible Conditions
- Torn Anterior Cruciate Ligament (ACL)
- Torn ACL
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post operative week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post operative week 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Quadriceps Strength of on POD 1 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block at 48 Hours After Discharge From PACU
Structure of femoral nerve
Secondary study objectives
Nausea
Quadriceps Strength on POD Week 6- Pts Receiving (1) Long-acting Single Bolus Adductor Canal Nerve Block Comparied to (2) Continuous Adductor Canal Nerve Catheter.
Subjective Assessment of Experience With Analgesia
+4 moreAwards & Highlights
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Long Acting Single Bolus Adductor Canal Nerve BlockActive Control5 Interventions
Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine \<20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal nerve block with 10cc of 0.5% ropivacaine and 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve.
Group II: Continuous Adductor Canal Nerve CatheterActive Control5 Interventions
Ultrasound guided femoral nerve block with 20cc of 2% mepivacaine \<20 minutes prior to in room time. Intraoperative patients will undergo initiation of general anesthesia under the care of the attending anesthesiologist assigned to the patient. Induction will include a propofol bolus and placement of laryngeal mask airway. Intraoperative opioid should be limited to no more than 150mcg of fentanyl. Upon completion of wound closure, appropriate dressing placement, emergence from anesthesia and removal of LMA, patients to be taken to PACU. Once adequately awake and alert this group will receive ultrasound guided adductor canal continuous nerve catheter using normal saline bolus followed by 1/8% bupivacaine infusion through catheter at 8cc/h.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
905 Previous Clinical Trials
934,040 Total Patients Enrolled
Christopher Sobey, MDPrincipal InvestigatorVanderbilt University Medical Center