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

Not Applicable

Completed

• Conditions: Arthroplasty, Replacement, Knee; Nerve Block
• Interventions: Other: Automated intermittent bolus

• Registration Number: NCT01226927
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-03
• Study Completion: 2010-04
• Status Verified: 2010-10
• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Last Update Submitted: 2010-10-21
• Study First Posted: 2010-10-22
• Last Update Posted: 2010-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion rate	Automated intermittent bolus	Patients received a continuous infusion of 0.2% ropivacaine at 10.1 mL/hr via their femoral nerve catheter.

Primary Outcome Measures

Name	Time	Method
Intravenous patient-controlled analgesia opioid consumption	Cumulative IV-PCA use was recorded until femoral nerve catheter removed on postoperative day 2.
Visual analog pain scale score	Preop; Immediately postoperatively in PACU; Postoperative day (POD) 0 at 8pm; POD 1 at 8am, 2pm & 8pm; POD 2 at 8am

Secondary Outcome Measures

Name	Time	Method
Visual analog scale patient satisfaction scores	POD 1 at 8am; POD 2 at 8am
Incidence of physician administered "rescue" boluses of the femoral nerve catheter
Hospital length of stay

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States