Clinical trial
A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block
Name
2017-0934
Description
A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor Canal Block with Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior cruciate ligament (ACL) reconstruction.
Trial arms
Trial start
2017-10-04
Estimated PCD
2021-03-16
Trial end
2024-06-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Bupivacaine
Bupivacaine will help treat pain and sensation after ACL repair
Arms:
Adductor Canal Block & IPACK (ACB/IPACK), Adductor Canal Block (ACB)
Ultrasound
Ultrasound will guide anesthesiologist in performing the different nerve blocks
Arms:
Adductor Canal Block & IPACK (ACB/IPACK), Adductor Canal Block (ACB)
Dexamethasone
Dexamethasone will be used to prolong block duration
Arms:
Adductor Canal Block & IPACK (ACB/IPACK), Adductor Canal Block (ACB)
Other names:
preservative free Dexamethasone
Size
78
Primary endpoint
Pain While at Rest
24 hours post-block administration
Eligibility criteria
Inclusion Criteria:
* Patients undergoing BTB ACL reconstruction with participating surgeon
* 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:
* Hepatic or renal insufficiency
* 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 78, 'type': 'ACTUAL'}}
Updated at
2023-08-30
1 organization
2 products
1 indication
Organization
Hospital for Special SurgeryProduct
BupivacaineIndication
ACL InjuryProduct
Dexamethasone