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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226927
• Other study ID #: HR 18880
• Status: Completed
• Phase: N/A
• First received: October 21, 2010
• Last updated: October 21, 2010
• Start date: April 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2010
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Nerve Block

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravenous patient-controlled analgesia opioid consumption		Cumulative IV-PCA use was recorded until femoral nerve catheter removed on postoperative day 2.	No
Primary	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	No
Secondary	Visual analog scale patient satisfaction scores		POD 1 at 8am; POD 2 at 8am	No
Secondary	Incidence of physician administered "rescue" boluses of the femoral nerve catheter			No
Secondary	Hospital length of stay			No