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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:
ClinicalTrials.gov Identifier:
NCT01226927
First Posted: October 22, 2010
Last Update Posted: October 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medical University of South Carolina
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Efficacy of Automated Intermittent Boluses for Continuous Femoral Nerve Block: a Prospective, Randomized Comparison to Continuous Infusions

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. ]
  • 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 Outcome Measures:
  • Visual analog scale patient satisfaction scores [ Time Frame: POD 1 at 8am; POD 2 at 8am ]
  • Incidence of physician administered "rescue" boluses of the femoral nerve catheter
  • Hospital length of stay

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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. doi: 10.1016/j.arth.2007.09.014. Epub 2008 Mar 4. Erratum in: Anaesth Intensive Care. 2016 May;44(3):428-9. J Arthroplasty. 2016 May;44(3):431.
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. doi: 10.1097/ALN.0b013e318191693a.
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. doi: 10.1213/ane.0b013e3181824164.

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
First Submitted: October 21, 2010
First Posted: October 22, 2010
Last Update Posted: October 22, 2010
Last Verified: October 2010


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