Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
78 participants
INTERVENTIONAL
2017-10-04
2020-04-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Adductor Canal Block (ACB)
The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
Bupivacaine
Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound
Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone
Dexamethasone will be used to prolong block duration
Adductor Canal Block & IPACK (ACB/IPACK)
The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
Bupivacaine
Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound
Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone
Dexamethasone will be used to prolong block duration
Interventions
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Bupivacaine
Bupivacaine will help treat pain and sensation after ACL repair
Ultrasound
Ultrasound will guide anesthesiologist in performing the different nerve blocks
Dexamethasone
Dexamethasone will be used to prolong block duration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 13 or greater
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (secondary outcomes include questionnaires validated in English only)
Exclusion Criteria
* Younger than 13 years old
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \> 40
* Diabetes
* American Society of Anesthesiology (ASA) score IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months, or daily morphine equivalent of \>5mg/day for one month)
* Non-English speaking
13 Years
80 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Jonathan Beathe, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-0934
Identifier Type: -
Identifier Source: org_study_id
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