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

NCT01226927 | Completed

• 1 other identifier: HR 18880
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee; Nerve Block

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (1)

Continuous infusion rate

ACTIVE COMPARATOR

Patients received a continuous infusion of 0.2% ropivacaine at 10.1 mL/hr via their femoral nerve catheter.

Other: Automated intermittent bolus

Interventions

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.

Continuous infusion rate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status 1 through 3
• elective, primary, unilateral TKA

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (9)

• 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. doi: 10.1097/00000542-199907000-00006.

  PMID: 10422923 BACKGROUND

• 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. doi: 10.1054/arth.2001.23622.

  PMID: 11402405 BACKGROUND

• 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.

  PMID: 18534496 BACKGROUND

• 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. doi: 10.1016/j.ijoa.2005.05.004.

  PMID: 16154735 BACKGROUND

• 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. doi: 10.1213/01.ane.0000197778.57615.1a.

  PMID: 16492849 BACKGROUND

• Taboada M, Rodriguez J, Bermudez M, Amor M, Ulloa B, Aneiros F, Sebate S, Cortes 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.

  PMID: 19104182 BACKGROUND

• 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.

  PMID: 3364765 BACKGROUND

• Taboada M, Rodriguez J, Bermudez M, Valino C, Ulloa B, Aneiros F, Gude F, Cortes 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.

  PMID: 18806065 BACKGROUND

• Hillegass MG, Field LC, Stewart SR, Borckardt JJ, Dong L, Kotlowski PE, Demos HA, Del Schutte H, Reeves ST. The efficacy of automated intermittent boluses for continuous femoral nerve block: a prospective, randomized comparison to continuous infusions. J Clin Anesth. 2013 Jun;25(4):281-8. doi: 10.1016/j.jclinane.2012.11.015. Epub 2013 May 16.

  PMID: 23685099 DERIVED

Study Officials

• Larry C. Field, M.D.

  Department of Anesthesia and Perioperative Medicine, Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: October 22, 2010

Record last verified: 2010-10

Locations

US (1)