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The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01226927
First received: October 21, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted

October 21, 2010
October 21, 2010
April 2009
March 2010   (final data collection date for primary outcome measure)
  • Intravenous patient-controlled analgesia opioid consumption [ Time Frame: Cumulative IV-PCA use was recorded until femoral nerve catheter removed on postoperative day 2. ] [ Designated as safety issue: No ]
  • Visual analog pain scale score [ Time Frame: Preop; Immediately postoperatively in PACU; Postoperative day (POD) 0 at 8pm; POD 1 at 8am, 2pm & 8pm; POD 2 at 8am ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Visual analog scale patient satisfaction scores [ Time Frame: POD 1 at 8am; POD 2 at 8am ] [ Designated as safety issue: No ]
  • Incidence of physician administered "rescue" boluses of the femoral nerve catheter [ Designated as safety issue: No ]
  • Hospital length of stay [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions
The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Arthroplasty, Replacement, Knee
  • Nerve Block
Other: Automated intermittent bolus
Automated intermittent bolus delivery method of 0.2% ropivacaine at 5 mL every 30 minutes with a basal infusion of 0.1 mL/hr.
Active Comparator: Continuous infusion rate
Patients received a continuous infusion of 0.2% ropivacaine at 10.1 mL/hr via their femoral nerve catheter.
Intervention: Other: Automated intermittent bolus

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
April 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01226927
HR 18880
No
Larry C. Field, M.D., Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina
Medical University of South Carolina
Not Provided
Principal Investigator: Larry C. Field, M.D. Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina
Medical University of South Carolina
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP