Adductor Canal Catheter Effectiveness and Safety Study

Total Knee Replacement Surgery Clinical Trial

— ACCESS  

Official title:

An Open-Label Randomized Noninferiority Clinical Trial of the Adductor Canal Catheter for Pain Control Post-Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04639128
• Other study ID #: 1488728
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: January 13, 2023

Study information

• Verified date: April 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. 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. To describe the incidence of complications related to ACC placement including infection, displacement, ACC-related clinic or emergency department (ED) visits

4. To conduct exploratory analyses to identify candidate predictors of differential response to the ACC

Description:

DESIGN: Randomized, open-label, two-arm, parallel-comparison noninferiority trial

POPULATION: Adults aged >18 years intending to undergo elective primary unilateral TKA at the Kaiser Permanente Northern California (KPNC), San Leandro Medical Center

INTERVENTION: Participants will be randomized to one of two treatment arms:

1. Adductor canal catheter placement in the pre-operative area immediately prior to TKA surgery OR

2. No adductor canal catheter placement

DURATION: The intervention phase will occur between randomization and three days postoperatively (or until the ACC is removed by the participant or the ACC falls out spontaneously among ACC-randomized participants); the primary outcome will be measured on postoperative day 2, secondary pain and medication outcomes will be collected for two weeks postoperatively and the electronic medical record (EMR) will be examined for evidence of adverse events at 30 days postoperatively

SAMPLE SIZE: 118 participants randomized using balanced allocation to the two study arms

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: January 13, 2023
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Patient ambulates independently

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Total Knee Replacement Surgery

Intervention

Device:
• Adductor Canal Catheter
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

Locations

Country	Name	City	State
United States	Kaiser Permanente San Leandro	San Leandro	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioid Consumption in the 15-day Postoperative Period	Total number of 5mg oxycodone tablets (provided to all patients on discharge) consumed over the 15-day postoperative period as recorded in the daily pain-and-medication postoperative diary	15 postoperative days