Total Knee Arthroplasty Utilizing Adductor Canal Block: Effect on Quadriceps Sparing

NCT02081911 | Terminated

• 1 other identifier: IRB #2014-005
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis (Knee)

Keywords

adductor canal; femoral; quadriceps

Outcome Measures

Primary Outcomes (1)

• Quadriceps function as assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve

  After CSE effect, but prior to peripheral block, quadriceps function will be assessed by non-invasive transcutaneous nerve stimulation of the femoral nerve by placing an ECG electrode over the femoral location (determined by U/S) in the inguinal groove. The threshold amperage that produces patellar motion in response to electrical stimulation will be recorded. This threshold amperage will serve as a baseline value. Following the peripheral nerve block, transcutaneous stimulation will be repeated and, if still possible to elicit quadriceps contractions in response to electrical stimulation, the resulting new threshold amperage will be measured. The new threshold amperage will be expressed as a percentage of the baseline value and serve as a quantitative functional indication of the extent of quadriceps paresis resulting from the peripheral nerve block. The primary outcome will be quadriceps paralysis - yes/no.

  15 minutes after the placement of the peripheral nerve block (femoral or adductor canal)

Secondary Outcomes (3)

• Threshold amperage as a percentage of the baseline value

  15 minutes after the placement of the peripheral nerve block

• Analgesic adequacy

  Resolution of the spinal anesthetic (2 hours post-op), 24 and 48 hours post-op

• Ability to complete a straight leg lift

  Holding area (baseline), at spinal resolution (2 hours post-op), 24 hours post-op and 48 hours post-op

Study Arms (3)

High volume Adductor canal block

EXPERIMENTAL

Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine

Procedure: High Volume Adductor Canal Block

Low volume Adductor Canal Block

EXPERIMENTAL

Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine

Procedure: Low Volume Adductor Canal Block

Femoral nerve block

EXPERIMENTAL

Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine

Procedure: Femoral Nerve Block

Interventions

High Volume Adductor Canal Block PROCEDURE

Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine

High volume Adductor canal block

Low Volume Adductor Canal Block PROCEDURE

Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine

Low volume Adductor Canal Block

Femoral Nerve Block PROCEDURE

Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine

Femoral nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (2)

• 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.

  PMID: 9024035 RESULT

• 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.

  PMID: 19901788 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• William Urmey, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 7, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 2, 2016

Record last verified: 2015-01

Locations

US (1)