Pain, Postoperative Clinical Trial
— FemVsACBOfficial title:
A Comparison Between Continuous Selective Femoral Blocks and Continuous Adductor Canal Blocks at Mid-Thigh in Total Knee Arthroplasty: What is the Best Method to Optimize Functional Achievement and Analgesia in Early Rehabilitation?
Verified date | February 2018 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Recently, several articles have suggested or reported that Adductor Canal Blocks (ACBs) offer
adequate or equal analgesia and may promote better performance in early rehabilitation
following Total Knee Arthroplasty (TKA) when compared to the more commonly used Femoral Nerve
Block (FNB). A common feature of these studies has been the use of moderate to high
concentration local anesthetics (e.g. 0.2% or 0.5% Ropivacaine respectively) which when
injected by a large motor nerve will inevitably cause weakness. However, the practice at our
institution has long been a continuous femoral nerve block (CFNB) with a lower concentration
local anesthetic (0.0625% Bupivacaine). Over the past several years the investigators have
performed several thousand CFNBs using this technique which has offered the advantage of
minimal motor weakness and adequate analgesia.
The primary goal of this study is to determine if our established practice of using a low
concentration continuous FNB inserted about 5cm caudal to the groin crease (the apex of the
femoral triangle) using a low infusion rate of 2ml/hr is comparable to the emerging practice
of inserting a Continuous Peripheral Nerve Block (CPNB) in the anatomic adductor canal (AC) -
infusing at 4ml/hr. A secondary goal is to study the effect of cumulative volume of local
anesthetic infused through a FNB when at a rate of 2ml/hr compared to a rate of 4ml/hr in the
48-hour postoperative period.
Definitions of the location of the adductor canal are debated heavily in literature, but they
seem to agree that the middle 1/3 of the thigh contains the proximal AC while the distal 1/3
of the thigh contains the adductor hiatus - the terminal end of the AC. Our study will
require placement of the continuous ACB no more distal than 20cm cephalad to the superior
pole of the patella due to placement prior to surgery and the need to keep the dressing out
of the operative field. The CACB catheter will also not be placed any more proximal than 20cm
distal to the ASIS. In addition to other exclusion criteria, these measurements will create
an exclusion for patients with an iliac-to-patella distance less than 40cm. Iliac to Patella
distance (IPD) will be measured at the pre-operative interview on the day of surgery with a
measuring tape. External palpable landmarks of the Anterior superior iliac spine and the
superior pole of the patella will be used.
The primary outcome is based upon the ability to perform rehabilitation exercises
postoperatively to the extent that criteria for discharge can be met. The primary outcome
measured is the time at which a patient gains the ability to successfully perform a 75-feet
unassisted walk. On the Day of Surgery (DOS), prior to any walking attempt, a secondary
outcome measure will be to perform a 5-second sustained straight leg raise. Other secondary
outcomes will be the number of days admitted prior to discharge, and average pain scores on
DOS, Postoperative Day (POD) #1, and POD#2. The Day of discharge will also be used as a
secondary outcome. Earlier discharge is becoming a goal of almost all healthcare systems to
minimize costs.
Status | Completed |
Enrollment | 62 |
Est. completion date | August 31, 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Able to consent to regional anesthesia and having primary total knee arthroplasty/replacement Exclusion Criteria: - Body-Mass Index >40 - Iliac to Patella Distance (IPD) <40cm - Pre-existing quadriceps weakness of involved surgical side Chronic opioid use (if using opioids within 4 weeks of surgery: excluded) |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center - Passavant Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Kevin King, DO |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery} | Ability to walk 75 feet if performed on POD#2 is usually considered the main criterion for discharge at UPMC Passavant. The patient is accompanied/supervised by physical therapist using a walker but without active intervention by therapist, unless necessary. The earliest day on which the patient achieves the 75-feet unassisted walk will be recorded for comparison among the arms/groups. | Participants will be followed for the duration of hospital stay, an average of 4 days | |
Secondary | Average Length of Stay (to be Reported in Hours After Surgery) | If pain is controlled and rehabilitation activity is optimal patient may be discharged at an earlier time | Participants will be followed for the duration of hospital stay; No patients will be discharged on the day of surgery; The earliest discharge would be at 24 hours. Those hospitalized beyond 96 hours will be excluded. | |
Secondary | Postoperative Pain, Average Reported Score 11-point Scale | The outcome is measured using a Numeric pain scale. The patient reports their average pain felt on postoperative day one, on a scale of 0 to 10 inclusive. Zero in this case indicates no pain at all and 10 indicates the worst pain they have ever felt. | postoperative day one | |
Secondary | Sustained Straight Leg Raise | Sustained Straight Leg Raise is the ability to elevate the heel and leg/knee off of bed for 5 seconds postoperatively after spinal anesthetic has resolved contralaterally. | Day of Surgery (DOS) - In Postoperative Recovery Unit, prior to any walking atempt |
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