Osteoarthritis (Knee) Clinical Trial
Official title:
Postoperative Pain Management Following Total Knee Arthroplasty Utilizing Adductor Canal Block: Effects on Pain Management and Quadriceps Sparing
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.
| Status | Terminated |
| Enrollment | 33 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Hospital for Special Surgery | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital for Special Surgery, New York |
United States,
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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Secondary | Threshold amperage as a percentage of the 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. | 15 minutes after the placement of the peripheral nerve block | No |
| Secondary | Analgesic adequacy | Analgesic adequacy as determined by pain scores (0-10) at spinal resolution (on average 2 hours post-op), 24 hours post-op and 48 hours post-op and daily epidural patient controlled analgesia consumption | Resolution of the spinal anesthetic (2 hours post-op), 24 and 48 hours post-op | No |
| Secondary | Ability to complete a straight leg lift | Ability to complete and hold (for 3 seconds) a straight leg lift (from supine position) against gravity as evidence of meaningful quadriceps function - performed in holding area (baseline), at spinal resolution (on average 2 hours post-op), 24 hours post-op and 48 hours post-op | Holding area (baseline), at spinal resolution (2 hours post-op), 24 hours post-op and 48 hours post-op | No |