A Trial Comparing Adductor Canal Catheter and Intraarticular Catheter Following Primary Total Knee Arthroplasty

NCT02497911 | Unknown Phase 4 DMC

• 1 other identifier: 00002109
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a prospective randomized controlled trial comparing intraarticular catheters and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).

Conditions

Acute Pain; Regional Anesthesia Morbidity

Keywords

Adductor Canal Catheter; Intraarticular Catheter; Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Post-operative pain

  postoperative pain as measured by Visual Analog Scale at rest and with movement

  immediately postoperative period to post-operative day # 2

Secondary Outcomes (3)

• Postoperative opioid consumption

  immediat postoperative period to postoperative day # 2

• Chronic post-surgical pain

  6-8 weeks post-operative

• Participation in Physical therapy

  immediate postoperative period to postoperative day #2

Study Arms (2)

Adductor Canal Catheter

EXPERIMENTAL

Postoperatively, patients will be brought to the PACU. The needle insertion site, approximately 10cm proximal to their operative knee, will be exposed. A sterile field will be utilized and the femoral artery is identified with a high frequency linear transducer proximal to the operative knee. 18g insulated Tuohy needle will be inserted in an out-of-plane approach through the sartorius muscle to a final location in close proximity to the saphenous nerve. Once satisfied with needle placement and following negative aspiration, 15 cc's of 0.5% ropivicaine will be injected through the needle under visualization. A 20-g multi-orifice catheter will be inserted approximately 4 cm beyond the needle tip and secured.

Procedure: Adductor Canal Catheter; Drug: Ropivicaine

Intraarticular Catheter

EXPERIMENTAL

Intra-articular catheters will be placed by the surgeon at the end of the procedure, before wound closure. A bupivacaine 0.5% infusion will be admin through the On-Q system and continued for 48 hours postoperatively.

Procedure: Intraarticular Catheter; Drug: Bupivicaine

Interventions

Adductor Canal Catheter PROCEDURE

0.5% Ropivicaine for primary block and 0.2% Ropivicaine infusion by OnQ Pump

Adductor Canal Catheter

Intraarticular Catheter PROCEDURE

0.5% Bupivicaine for primary block and 0.125% Bupivicaine infusion by OnQ Pump

Intraarticular Catheter

Ropivicaine DRUG

Adductor Canal Catheter

Bupivicaine DRUG

Intraarticular Catheter

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-85
• American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3.
• Undergoing Unilateral, Primary, Total Knee Arthroplasty
• English as native language

You may not qualify if:

• Patient refusal
• History of opioid dependence
• Contraindication to peripheral nerve block
• Pre-existing significant neuropathy

Sponsors & Collaborators

• Thomas Jefferson University: lead

Related Publications (5)

• Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.

  PMID: 18627367 BACKGROUND

• Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.

  PMID: 21394001 BACKGROUND

• Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.

  PMID: 22221014 BACKGROUND

• Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.

  PMID: 20571832 BACKGROUND

• Essving P, Axelsson K, Aberg E, Spannar H, Gupta A, Lundin A. Local infiltration analgesia versus intrathecal morphine for postoperative pain management after total knee arthroplasty: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):926-33. doi: 10.1213/ANE.0b013e3182288deb. Epub 2011 Aug 4.

  PMID: 21821506 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaime L Baratta, MD

  Sidney Kimmel Medical Center at Thomas Jefferson University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: July 15, 2015
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 23, 2015

Record last verified: 2015-10