N/A
Completed N=126
Adductor Canal Catheter Effectiveness and Safety Study
Total Knee Replacement Surgery
Source: ClinicalTrials.gov NCT04639128 ↗
Enrolled (actual)
126
Serious AEs
3.2%
Results posted
Apr 2024
Primary outcomePrimary: Pain Numerical Rating Scale — 6.38; 5.31 score on a scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Numerical Rating Scale |
6.38; 5.31 | — |
| SECONDARY Opioid Consumption in the 15-day Postoperative Period |
41.9; 46.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT04639128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.