Clinical trial NCT02497911: A Trial Comparing Adductor Canal Catheter and Intraarticular Catheter Following Primary Total Knee Arthroplasty
Official title: A Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Intra-articular Catheter (IAC) Following Primary Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Pain
Regional Anesthesia Morbidity
Keywords: Adductor Canal Catheter
Intraarticular Catheter
Arthroplasty, Replacement, Knee
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-operative pain
timeFrame: immediately postoperative period to post-operative day # 2
Secondary outcomes:
measure: Postoperative opioid consumption
timeFrame: immediat postoperative period to postoperative day # 2
measure: Chronic post-surgical pain
timeFrame: 6-8 weeks post-operative
measure: Participation in Physical therapy
timeFrame: immediate postoperative period to postoperative day #2
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Medical Center at Thomas Jefferson University Hospital
name: Jaime L Baratta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.