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

NCT ID: NCT02497911

Last Updated: 2015-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-11-30

Brief Summary

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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).

Detailed Description

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The study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary TKA. Eligible primary TKA patients must be ASA I - III and require less than 20 mg oxycodone daily (or its equivalent). Exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/motor disorder involving operative limb, non-english speaking, ASA IV or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with Cr \> 2.0 and hepatic failure. When patients agree to participate in the study the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, painDETECT score (form included), WOMAC score (form included) and baseline Pain Management Questionnaire. When designated through randomization, intra-articular catheters will be placed intraoperatively by the surgeons, per usual protocol. ACC's will be placed postoperatively in the PACU. The catheters will exit the bandage in a similar fashion to blind the personnel collecting data, postoperatively. Those collecting data will not be blinded from identifying patients in the control group, as no catheter will exit the bandage. Potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. The preceding are commonly listed though infrequent complications of both procedures. Continuous ultrasound will guide the placement of the ACC.

Conditions

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Acute Pain Regional Anesthesia Morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Adductor Canal Catheter

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.

Group Type EXPERIMENTAL

Adductor Canal Catheter

Intervention Type PROCEDURE

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

Ropivicaine

Intervention Type DRUG

Intraarticular Catheter

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.

Group Type EXPERIMENTAL

Intraarticular Catheter

Intervention Type PROCEDURE

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

Bupivicaine

Intervention Type DRUG

Interventions

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Adductor Canal Catheter

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

Intervention Type PROCEDURE

Intraarticular Catheter

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

Intervention Type PROCEDURE

Ropivicaine

Intervention Type DRUG

Bupivicaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patient refusal
* History of opioid dependence
* Contraindication to peripheral nerve block
* Pre-existing significant neuropathy
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Jaime Baratta

Clinical Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime L Baratta, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Medical Center at Thomas Jefferson University Hospital

References

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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.

Reference Type BACKGROUND
PMID: 18627367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21394001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22221014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20571832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21821506 (View on PubMed)

Other Identifiers

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00002109

Identifier Type: -

Identifier Source: org_study_id

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