Clinical trial NCT06580899: Intra-Articular Catheter Total Knee Arthroplasty
Official title: Effectiveness of Continuous Local Infiltration Analgesia Intra-Articular Catheters for Pain Relief in Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Continuous Local Infiltration Analgesia
Intra-articular Catheter
Total Knee Arthroplasty
Keywords: continuous local infiltration analgesia
intra-articular catheter
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, randomized clinical trial evaluating three groups. The groups are:

Group 1 (Control): Subjects that receive only the existing standard-of-care multimodal pain management protocol and do not receive post-operative intra-articular catheter.

Group 2 (Investigational Treatment/Intervention): Subjects that receive the brand 1 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period.

Group 3 (Investigational Treatment/Intervention): Subjects that receive the newer brand 2 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period.

Detailed description: The purpose of this study is to determine the effects of one of two continuous local infiltration analgesia (intra-articular catheter device) on patient postoperative pain scores following primary unilateral total knee arthroplasty in comparison to no addition of an intra-articular (IART) catheter post total knee arthroplasty (TKA). The investigators hypothesize that if patients undergoing primary unilateral TKA surgery receive an intra-articular catheter device that continuously delivers local infiltration analgesia in the postoperative period, then their postoperative pain scores on the visual analog scale will decrease. Secondary objectives will include determining the role of intraoperative tourniquet use on thigh versus knee postoperative pain and quantifying the amount of additional postoperative patient communication related to the intra-articular catheter device.

Previous literature demonstrates conflicting results on the effects of continuous local infiltration analgesia on postoperative pain management following TKA. The proposed study incorporates a well-designed and substantially powered study to directly compare patient postoperative pain scores with and without the use of an intra-articular catheter device, which will provide additional evidence and clarity to the literature.

If the intra-articular catheter is determined to provide meaningful reductions in postoperative pain, this directly benefits patients undergoing TKA surgery. Decreases in postoperative pain allow for increased patient comfort and earlier functional knee rehabilitation following surgery, both of which promote a faster recovery. A favorable intra-articular catheter study, in addition to the previous literature on continuous local infiltration analgesia, has the potential to change the previous standard of care following TKA surgery to add intra-articular catheter or similar devices as an evidence-based treatment in multimodal pain protocols. If the intra-articular catheter is determined not to provide clinically significant reductions in postoperative pain, then these devices have no substantial benefit to the patient and orthopedic surgeons can stop prescribing them. TKA surgery would become more cost-effective as the additional cost associated with the intra-articular catheter device will no longer be charged. The intraarticular intra-articular catheter patient pump has a rare, but small risk of infection due to the portal from the external environment to the knee joint. This additional catheter infection risk will be eliminated if future use of the intra-articular catheter device subsides.

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing elective outpatient unilateral TKA at Mallard Creek Surgery Center
2. Subjects ≥ 18 years or age
3. Subjects willing and able to provide written informed consent to participate in this study
4. Subjects who are indicated to use an intra-articular catheter pump system

Exclusion Criteria:

1. Subjects \< 18 years of age
2. Subjects with history of chronic pain, neuropathic pain, or currently enrolled in pain management agreement
3. Subjects undergoing bilateral TKA
4. Subjects taking opiate pain medication preoperatively within 6 weeks of surgery date.
5. Subjects allergic to any components or treatment medications

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 2 days postoperative, 2 weeks postoperative
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.)
timeFrame: 6 weeks postoperative
Other outcomes:
measure: Anesthesia Type
timeFrame: at time of surgery
measure: tourniquet times
timeFrame: at time of surgery
measure: range of motion
timeFrame: preoperative, 2 weeks postoperative, 6 weeks postoperative
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute, Inc.
state: North Carolina
Study officials:
References:
citation: Gunaratne R, Pratt DN, Banda J, Fick DP, Khan RJK, Robertson BW. Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature. J Arthroplasty. 2017 Dec;32(12):3854-3860. doi: 10.1016/j.arth.2017.07.021. Epub 2017 Jul 21.
citation: Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.
citation: Horlocker TT. Pain management in total joint arthroplasty: a historical review. Orthopedics. 2010 Sep;33(9 Suppl):14-9. doi: 10.3928/01477447-20100722-65.
citation: Soffin EM, Memtsoudis SG. Anesthesia and analgesia for total knee arthroplasty. Minerva Anestesiol. 2018 Dec;84(12):1406-1412. doi: 10.23736/S0375-9393.18.12383-2. Epub 2018 May 28.
citation: Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S, Callaghan JJ. Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. J Bone Joint Surg Am. 2013 Feb 6;95(3):193-9. doi: 10.2106/JBJS.K.01682.