Status:
TERMINATED
Continuous Vs Single Shot Block After ACL
Lead Sponsor:
Northwell Health
Conditions:
ACL Injury
Eligibility:
All Genders
16+ years
Phase:
EARLY_PHASE1
Brief Summary
The investigators will be randomizing patients to either receive an adductor canal block in the operating room postoperatively as single shot of 20-30cc bupivacaine or to have a catheter inserted into...
Detailed Description
Screening evaluation will occur during the preoperative visit prior to surgery which generally occurs within 28 days prior to surgery. No separate screening is indicated in this study. Patients will ...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged \>16 years old
- In good general health as evidenced by medical history and deemed medically healthy enough to tolerate surgery by the patient's primary care physician
- MRI with evidence of ACL tear, and wanting to have an ACL reconstruction surgery
- Ability to take oral medication and be willing to adhere to the study intervention, including telephone calls
- Agrees to complete surveys required on the days specified between 5-9PM
Exclusion
- Current daily opioid requirement exceeding the equivalent of 15mg morphine
- Daily prescription of corticosteroid, tricyclic antidepressant, gabapentin, or tramadol
- Carrying the diagnosis of chronic pain syndrome, uncontrolled anxiety, history of schizophrenia or related psychiatric disorders
- History of alcohol or drug abuse/addiction
- History of preexisting nerve damage in the surgical extremity
- Knee surgery (same knee) in the previous 12 weeks
- Anticipated knee surgery in the other knee planned in the ensuing 6 months
- Diabetic patients with blood sugar values exceeding 250 mg/dl in the previous month
- BMI \>40Kg/m2
- Pregnancy, which will be determined by a serum or urine HCG test on the day of surgery.
- Incarceration
- Inability to communicate with staff, including being unreachable by telephone
- Revision ACL reconstruction
- Patient reconsideration after initial agreement.
- Non-English speaking subjects
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04101682
Start Date
September 25 2020
End Date
May 17 2022
Last Update
October 18 2023
Active Locations (1)
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1
Plainview Hospital
Plainview, New York, United States, 11803