Clinical trial NCT01226927: The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions
Official title: The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Nerve Block
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2010-10-22
Enrollment: 45
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 optimal infusion technique (continuous rate vs. intermittent bolus) for peripheral nerve blocks has not been established. To our knowledge, this is the first study to compare the efficacy of an automated intermittent bolus technique to a continuous rate of infusion of local anesthetic in femoral nerve catheters. We hypothesized that the intermittent bolus technique would provide enhanced analgesia compared to a continuous infusion rate as assessed by intravenous patient-controlled analgesia (IV-PCA) hydromorphone consumption and visual analog scale (VAS) pain scores.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 through 3
* elective, primary, unilateral TKA

Exclusion Criteria:

* patient refusal
* pregnancy
* diabetic neuropathy or any other neurologic or neuromuscular disease
* rheumatoid arthritis
* current coagulopathy
* skin infection at needle insertion site for the femoral or sciatic blocks
* significant renal or hepatic impairment
* unsuccessful femoral or sciatic block or femoral catheter placement
* femoral catheter dislodgement after placement
* inability to understand VAS pain scales
* inability to use an IV-PCA pump

Primary outcomes:
measure: Intravenous patient-controlled analgesia opioid consumption
timeFrame: Cumulative IV-PCA use was recorded until femoral nerve catheter removed on postoperative day 2.
measure: Visual analog pain scale score
timeFrame: Preop; Immediately postoperatively in PACU; Postoperative day (POD) 0 at 8pm; POD 1 at 8am, 2pm & 8pm; POD 2 at 8am
Secondary outcomes:
measure: Visual analog scale patient satisfaction scores
timeFrame: POD 1 at 8am; POD 2 at 8am
measure: Incidence of physician administered "rescue" boluses of the femoral nerve catheter
measure: Hospital length of stay
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina
name: Larry C. Field, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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