Adductor Canal Catheter Effectiveness and Safety Study

NCT ID: NCT04639128

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2023-01-13

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. 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

Detailed 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

Conditions

Total Knee Replacement Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No-Device

No placement of an adductor canal catheter

Group Type: NO_INTERVENTION

No interventions assigned to this group

Device

Placement of an adductor canal catheter

Group Type: EXPERIMENTAL

Adductor Canal Catheter

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian Hinman, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente San Leandro

San Leandro, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26227922 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19916251 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24401769 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1488728

Identifier Type: -

Identifier Source: org_study_id