Adductor Canal Catheter Effectiveness and Safety Study

NCT04639128 | Completed Results DMC FDA Device

• 1 other identifier: 1488728
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

PRIMARY OBJECTIVE: Compare the effect of usual care with an adductor canal catheter (ACC) containing ropivacaine to the effect of usual care without an ACC on the second-postoperative-day pain levels among patients undergoing elective primary unilateral total knee arthroplasty (TKA) SECONDARY OBJECTIVES: Among a sample of patients undergoing elective primary unilateral TKA who receive peri-articular anesthetic injections:

1. 1.To compare the overall two-week levels of postoperative pain between those participants randomized to ACCs containing ropivacaine and those participants randomized to usual care without an ACC
2. 2.To compare the use of opioid medications (in mean total morphine milligram equivalents) between those participants randomized to ACCs containing ropivacaine and those participants randomized to usual care without an ACC over the two-week postoperative period
3. 3.To describe the incidence of complications related to ACC placement including infection, displacement, ACC-related clinic or emergency department (ED) visits
4. 4.To conduct exploratory analyses to identify candidate predictors of differential response to the ACC

Conditions

Total Knee Replacement Surgery

Keywords

analgesia; surgery; device

Outcome Measures

Primary Outcomes (1)

• Pain Numerical Rating Scale

  Ordinal 0-to-10 point scale of pain severity Minimum value: 0 Maximum value: 10 Higher scores mean more pain

  Second postoperative day

Secondary Outcomes (1)

• Opioid Consumption in the 15-day Postoperative Period

  15 postoperative days

Study Arms (2)

No-Device

NO INTERVENTION

No placement of an adductor canal catheter

Device

EXPERIMENTAL

Placement of an adductor canal catheter

Device: Adductor Canal Catheter

Interventions

Adductor Canal Catheter DEVICE

The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days

Device

Eligibility Criteria

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

You may qualify if:

• Intending to undergo elective primary unilateral TKA at the Kaiser Permanente Northern California, San Leandro Medical Center
• Patient ambulates independently

You may not qualify if:

• Patient declines use of ACC
• Surgeon decides that an ACC will not be placed for any reason
• Known hypersensitivity to ropivacaine or any alternative anesthetic for ACC use
• Hypersensitivity or inability to tolerate peri-articular injections of clonidine, epinephrine, bupivacaine and ketorolac
• Any evidence of substance-use disorder in past year
• Non-English speaking
• Failure to complete all baseline study instruments prior to surgery
• Requires secondary procedure at time of TKA (e.g., removal of hardware)
• Not intending to use spinal anesthesia for TKA procedure
• Actively enrolled in KPNC chronic-pain program
• Having been prescribed long-acting opioid (e.g., Oxycontin, MS Contin) within 90 days prior to enrollment
• Inability to tolerate any oral NSAID or acetaminophen or any short-acting opioid

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

Location

Related Publications (3)

• Song MH, Kim BH, Ahn SJ, Yoo SH, Kang SW, Kim YJ, Kim DH. Peri-articular injections of local anaesthesia can replace patient-controlled analgesia after total knee arthroplasty: a randomised controlled study. Int Orthop. 2016 Feb;40(2):295-9. doi: 10.1007/s00264-015-2940-2. Epub 2015 Jul 31.

  PMID: 26227922 BACKGROUND

• Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84.

  PMID: 19916251 BACKGROUND

• Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.

  PMID: 24401769 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Adrian Hinman
• Organization: The Permanente Medical Group

adrian.d.hinman@kp.org

510-454-7292

Study Officials

• Adrian Hinman, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 20, 2020
• Study Start: March 15, 2021
• Primary Completion: December 14, 2022
• Study Completion: January 13, 2023
• Last Updated: April 25, 2024
• Results First Posted: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)