Clinical trial
Continuous Vs Single Shot Adductor Canal Block After ACL Reconstruction - A Randomized Study
Name
18-0811
Description
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 the adductor canal which will be attached up to a continuous infusion pump of bupivacaine that will have a set flow rate over the next couple days. The investigators' hypothesis is that patients will have better pain control, sleep, and decreased opioid consumption with the use of a continuous infusion pump
Trial arms
Trial start
2020-09-25
Estimated PCD
2022-05-17
Trial end
2022-05-17
Status
Terminated
Phase
Early phase I
Treatment
Bupivacaine
Administered by an anesthesiologist or certified nurse anesthetist, under ultrasound guidance a catheter placed overlying the nerve sheath. This catheter is then connected to a device with a reservoir that administers local anesthetic at a set rate.
Arms:
Continuous Block, Single Shot
Size
9
Primary endpoint
Pain at Rest
Day 1
Pain at Rest
Day 2
Pain at Rest
Day 3
Pain at Rest
Day 4
Pain at Rest
Day 7
Pain at Rest
Day 14
Worst Pain in the past 24 hours
Day 1
Worst Pain in the past 24 hours
Day 2
Worst Pain in the past 24 hours
Day 3
Worst Pain in the past 24 hours
Day 4
Worst Pain in the past 24 hours
Day 7
Worst Pain in the past 24 hours
Day 14
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}
Updated at
2023-10-18
1 organization
1 product
1 indication
Organization
Northwell HealthProduct
BupivacaineIndication
Anterior Cruciate Ligament (ACL) Injury