Post-Operative Colonization Rates of Femoral Nerve Catheters Treated With Chlorhexidine-Impregnated Patch
Information source: University of Wisconsin, Madison
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Catheter Infections; Spinal Catheter (Epidural) (Subdural); Complications, Infection or Inflammation
Intervention: Chlorhexidine impregnated patch (Biopatch) (Device)
Phase: Phase 4
Status: Completed
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s): Kristopher M Schroeder, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison
Summary
Joint replacement is becoming an increasingly common procedure. In 2005, 534,000 total knee
arthroplasties (TKA) were performed in the United States which is at a rate of 18. 1 per
10,000 individuals, and the demand for primary TKA is projected to grow by 673% by 2030.
Effective post-operative analgesia is an important component with regards to patient
satisfaction and hospital stay. Regional anesthesia has been shown to decrease duration of
surgery, need for transfusion, post-operative nausea and vomiting, and the incidence of
thromboembolic disease in patients undergoing total knee or total hip replacement when
compared with general anesthesia. Post-operatively, regional anesthesia has been shown to
reduce pain scores and/or morphine consumption as well as opioid-related adverse effects.
Epidural catheter or spinal anesthesia has become the standard of care at the University of
Wisconsin-Madison for intraoperative management of TKA patients. General anesthesia is
still occasionally used for patients that would strongly prefer a general anesthetic, those
that are taking anticoagulation medications or with a coagulopathy, those with previous back
surgery, and those with certain neurologic conditions such as multiple sclerosis or spina
bifida. Comparison studies between lumbar epidural analgesia and femoral nerve catheters
(FNC) for postoperative analgesia following TKA show no significant difference in pain
scores, morphine consumption, or post-operative nausea and vomiting. However, epidural
analgesia has been associated with higher incidence of hypotension and urinary retention.
FNC's placed for postoperative pain allow patients to ambulate more effectively as there
should not be much of a lower extremity motor block. Patients with a FNC for postoperative
analgesia also do not require a urinary catheter which eliminates a common source of
infection in postoperative patients. FNCs have also demonstrated improved rehabilitation
times and decreased hospital stays which has led to an increased insertion rate of FNCs for
postoperative analgesia following TKA at the University of Wisconsin.
Pyarthrosis is a fairly common complication occurring at a rate of 2% following primary and
5. 6% following revision TKA. Infection can be a devastating complication following
implantation of joint hardware often leading to extended hospitalization/rehabilitation
stays and return trips to the operating room. The average billed charges for all types of
revision TKA procedures was $49,360 with average length of stay of 5. 1 days. Indwelling
lines are a known infection risk and indwelling lines in the femoral region are known to be
associated with a high incidence of catheter colonization. At 48 hours, Cuvillon et. al.
found that 57% of FNCs placed without the use of a chlorhexidine impregnated patch had
positive bacterial colonization. They also described three cases of transient bacteremia
secondary to FNCs in the 208 catheters that they analyzed.
Chlorhexidine impregnated patches also known as "biopatches" have been shown to reduce the
incidence of bacterial colonization and infection of various indwelling lines including
epidurals and central venous catheters. Currently no standard of care exists that requires
the use of biopatches for FNCs. The investigators propose studying the use of the biopatch
to reduce the incidence of bacterial colonization of femoral nerve catheters.
The investigators will study the efficacy of the biopatch at decreasing the rate of
bacterial colonization of FNCs in TKA patients. The FNCs will be inserted in the standard
fashion and removed at the end of therapy. Typically the FNC infusion will continue until
the morning of post-operation day (POD) #1 or 2. The process for FNC insertion first
involves sterile prep and drape of the femoral region. Full sterile technique will be
utilized including gown, gloves, and mask. Ultrasound guidance is then commonly utilized to
identify the femoral nerve. Following patient sedation and skin infiltration with local
anesthetic, a tuohy needle is inserted adjacent to the femoral nerve. A catheter is then
threaded through the needle in close proximity to the femoral nerve. Patients will be
randomized to either no chlorhexidine impregnated patch or to a chlorhexidine impregnated
patch that will be located at the catheter exit site. On the morning of POD 1 or 2, the FNC
infusion will be discontinued. Typically, Twenty-four to forty-eight hours after catheter
insertion, it will be removed in a sterile fashion and the skin surrounding the catheter
exit site will be swabbed and the distal catheter tip will be sent for culture to determine
bacterial colonization. In addition, the investigators will interview patients and review
clinical data to determine signs of infection and/or catheter tip colonization rates.
Clinical Details
Official title: Prospective Randomized Control Trial of Post-Operative Colonization Rates of Femoral Nerve Catheters With the Use of Chlorhexidine-Impregnated Patch
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Catheter Tip ColonizationFemoral Nerve Catheter Bacterial Colonization
Secondary outcome: Catheter Insertion Site Colonization.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients age 18-85 undergoing elective knee arthroplasty who elect to have a femoral
nerve block catheter placed for postoperative analgesia.
Exclusion Criteria:
- Allergy to local anesthetics,
- local or generalized infection or inflammation,
- current antibiotic therapy,
- immunocompromised patients,
- a history of chronic steroid use,
- neurological deficits,
- pregnancy,
- prisoners,
- refusal to participate,
- primary language other than English,
- and patients currently participating in a study.
Locations and Contacts
University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin 53792, United States
Additional Information
Starting date: August 2011
Last updated: June 27, 2012
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