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Completed

NCT Number: NCT01226927

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee Nerve Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated intermittent bolus

Other

Automated intermittent bolus delivery method of 0.2% ropivacaine at 5 mL every 30 minutes with a basal infusion of 0.1 mL/hr.

Primary outcomes

  1. Intravenous patient-controlled analgesia opioid consumption

    Time frame: Cumulative IV-PCA use was recorded until femoral nerve catheter removed on postoperative day 2.

  2. 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

Secondary outcomes

  1. Visual analog scale patient satisfaction scores

    Time frame: POD 1 at 8am; POD 2 at 8am

  2. Incidence of physician administered "rescue" boluses of the femoral nerve catheter

  3. Hospital length of stay

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 22, 2010
Registry last updated
Oct 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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