Clinical trial NCT02081911: Total Knee Arthroplasty Utilizing Adductor Canal Block: Effect on Quadriceps Sparing
Official title: Postoperative Pain Management Following Total Knee Arthroplasty Utilizing Adductor Canal Block: Effects on Pain Management and Quadriceps Sparing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis (Knee)
Keywords: adductor canal
femoral
quadriceps
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether there is quantitative motor-sparing of the quadriceps muscles following adductor canal nerve block versus femoral nerve block. Patients will be randomly placed into one of three treatment groups: 1) Femoral nerve block, 2) Adductor canal nerve block - low volume, or 3) Adductor canal nerve block - high volume. Quadriceps function will be assessed in the operating room using a skin patch and electrical stimulation. Follow up visits with the patients will continue over the course of 2 days during patient's stay at the hospital. A total of 60 patients will be enrolled for the study.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing primary unilateral total knee arthroplasty
* Planned use of combined spinal epidural (CSE) anesthesia
* Ability to follow study protocol

Exclusion Criteria:

* Contraindication to a spinal or epidural anesthetic
* Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months)
* Allergy to local anesthetics
* Pre-existing neuropathy or weakness of the operative limb
* Any neuromuscular disorder
* Diabetes type I and II
* Contraindication to a femoral nerve block or adductor canal nerve block
* Allergy or intolerance to any of the study medications
* BMI \> 35 kg/m2

Primary outcomes:
measure: Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve
timeFrame: 15 minutes after the placement of the peripheral nerve block (femoral or adductor canal)
Secondary outcomes:
measure: Threshold amperage as a percentage of the baseline value
timeFrame: 15 minutes after the placement of the peripheral nerve block
measure: Analgesic adequacy
timeFrame: Resolution of the spinal anesthetic (2 hours post-op), 24 and 48 hours post-op
measure: Ability to complete a straight leg lift
timeFrame: Holding area (baseline), at spinal resolution (2 hours post-op), 24 hours post-op and 48 hours post-op
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: William Urmey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vloka JD, Hadzic A, Lesser JB, Kitain E, Geatz H, April EW, Thys DM. A common epineural sheath for the nerves in the popliteal fossa and its possible implications for sciatic nerve block. Anesth Analg. 1997 Feb;84(2):387-90. doi: 10.1097/00000539-199702000-00028.
citation: Davis JJ, Bond TS, Swenson JD. Adductor canal block: more than just the saphenous nerve? Reg Anesth Pain Med. 2009 Nov-Dec;34(6):618-9. doi: 10.1097/AAP.0b013e3181bfbf00. No abstract available.