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
  Purpose

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.


Condition Intervention
Arthroplasty, Replacement, Knee
Nerve Block
Other: Automated intermittent bolus

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: April 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous infusion rate
Patients received a continuous infusion of 0.2% ropivacaine at 10.1 mL/hr via their femoral nerve catheter.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01226927

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Larry C. Field, M.D. Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Larry C. Field, M.D., Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01226927     History of Changes
Other Study ID Numbers: HR 18880
Study First Received: October 21, 2010
Last Updated: October 21, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 21, 2014