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

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:

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

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

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:

Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15.

Chelly JE, Greger J, Gebhard R, Coupe K, Clyburn TA, Buckle R, Criswell A. Continuous femoral blocks improve recovery and outcome of patients undergoing total knee arthroplasty. J Arthroplasty. 2001 Jun;16(4):436-45.

Shum CF, Lo NN, Yeo SJ, Yang KY, Chong HC, Yeo SN. Continuous femoral nerve block in total knee arthroplasty: immediate and two-year outcomes. J Arthroplasty. 2009 Feb;24(2):204-9. Epub 2008 Mar 4.

Lim Y, Sia AT, Ocampo C. Automated regular boluses for epidural analgesia: a comparison with continuous infusion. Int J Obstet Anesth. 2005 Oct;14(4):305-9.

Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9.

Taboada M, Rodríguez J, Bermudez M, Amor M, Ulloa B, Aneiros F, Sebate S, Cortés J, Alvarez J, Atanassoff PG. Comparison of continuous infusion versus automated bolus for postoperative patient-controlled analgesia with popliteal sciatic nerve catheters. Anesthesiology. 2009 Jan;110(1):150-4.

Ferrante FM, Orav EJ, Rocco AG, Gallo J. A statistical model for pain in patient-controlled analgesia and conventional intramuscular opioid regimens. Anesth Analg. 1988 May;67(5):457-61.

Taboada M, Rodríguez J, Bermudez M, Valiño C, Ulloa B, Aneiros F, Gude F, Cortés J, Alvarez J, Atanassoff PG. A "new" automated bolus technique for continuous popliteal block: a prospective, randomized comparison with a continuous infusion technique. Anesth Analg. 2008 Oct;107(4):1433-7.

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 May 16, 2013