Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following total knee arthroplasty: a randomized, double-masked, sham-controlled pilot study.

BACKGROUND: Percutaneous auricular nerve stimulation (neuromodulation) is an analgesic technique involving the percutaneous implantation of multiple leads at various points on/around the ear followed by the delivery of electric current using an external pulse generator. A device is currently available within the USA cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. The current randomized, controlled pilot study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent definitive clinical trial and (2) estimate the treatment effect of auricular neuromodulation on postoperative pain and opioid consumption following total knee arthroplasty. METHODS: Within the recovery room following primary, unilateral, total knee arthroplasty, an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) was applied using three percutaneous leads and one ground electrode. Participants were randomized to 5 days of either electrical stimulation or sham stimulation in a double-masked fashion. Participants were discharged with the stimulator in situ and removed the disposable devices at home. The dual primary treatment effect outcome measures were the cumulative opioid use (oral oxycodone) and the mean of the "average" daily pain measured with the Numeric Rating Scale for the first 5 postoperative days. RESULTS: During the first five postoperative days, oxycodone consumption in participants given active stimulation (n=15) was a median (IQR) of 4 mg (2-12) vs 13 mg (5-23) in patients given sham (n=15) treatment (p=0.039). During this same period, the average pain intensity in patients given active stimulation was a median (IQR) of 2.5 (1.5-3.3) vs 4.0 (3.6-4.8) in those given sham (p=0.014). Awakenings due to pain over all eight postoperative nights in participants given active stimulation was a median (IQR) of 5 (3-8) vs 11 (4-14) in those given sham (p<0.001). No device-related localized cutaneous irritation, systemic side effects, or other adverse events were identified. CONCLUSIONS: Percutaneous auricular neuromodulation reduced pain scores and opioid requirements during the initial week after total knee arthroplasty. Given the ease of application as well as the lack of systemic side effects and reported complications, a definitive clinical trial appears warranted. TRIAL REGISTRATION NUMBER: NCT05521516.

A Randomized Controlled Pilot Study Using Ultrasound-Guided Percutaneous Cryoneurolysis of the Infrapatellar Branch of the Saphenous Nerve for Analgesia Following Total Knee Arthroplasty.

INTRODUCTION: Total knee arthroplasty (TKA) is frequently associated with severe, prolonged postsurgical pain, and therefore local anesthetic-based peripheral nerve blocks are commonly used for postoperative analgesia. Cryoneurolysis involves the use of freezing temperatures to provide a reversible sensory (and motor) block with a duration measured in weeks and months, more commensurate with the typical period of post-TKA pain. We therefore conducted a randomized controlled pilot study to evaluate the use of this modality for the treatment of pain following TKA to (1) determine the feasibility of and optimize the study protocol for a subsequent definitive clinical trial; and (2) estimate analgesia and opioid reduction within the first 3 postoperative weeks. METHODS: A convenience sample of 16 patients undergoing primary TKA with a single-injection and/or continuous adductor canal nerve block were randomized to receive either active cryoneurolysis or a sham procedure targeting the infrapatellar branch of the saphenous nerve, in a participant-masked fashion. This was a pilot study with a relatively small number of participants, and therefore resulting data were not analyzed statistically. RESULTS: Compared with participants receiving sham, the active treatment group reported slightly lower average and worst pain scores as well as opioid consumption and sleep disturbances due to pain at a majority of postoperative time points between postoperative days (POD) 4-21. CONCLUSIONS: Preoperative ultrasound-guided cryoneurolysis of the infrapatellar branch of the saphenous nerve is feasible and may provide analgesic benefits for multiple weeks following TKA. A definitive randomized controlled trial appears warranted.

Metabolic Syndrome Is Associated With Higher Risk of Wound Complications After Total Hip Arthroplasty.

BACKGROUND: Obesity is prevalent among patients undergoing total hip arthroplasty and has been associated with the risk of wound complications, particularly when an anterior approach is used. However, most studies have focused on obesity defined by the body mass index (BMI), without considering the metabolic effects of adiposity. Thus, in this study, we investigated the independent effects of the BMI and metabolic syndrome on wound complications after total hip arthroplasty. METHODS: Among 804 consecutive patients undergoing total hip arthroplasty between October 2013 and July 2016, we evaluated the associations between obesity (BMI ≥30 mg/kg2), metabolic syndrome (defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines), and wound complication (defined as documented wound dehiscence, drainage, erythema, hematoma, infection, or seroma) over a 1-year follow-up period. We used Cox proportional hazards models adjusting for demographics, smoking status, and hospital length of stay. RESULTS: Patients' mean age at time of surgery was 62.0 ± 11.9 years. Forty-seven percent were male, 27.9% were obese, and 11.6% met the definition for metabolic syndrome. Metabolic syndrome was associated with a 4-fold higher risk of wound complication (95% confidence interval: 1.4-11.1) after adjusting for all covariates including the BMI. In unadjusted analysis, obesity was associated with a higher risk of wound complication (hazard ratio: 2.8, 95% confidence interval: 1.3-6.2). However, obesity was not associated with the risk of wound complication after adjusting for the metabolic syndrome (P = .16). CONCLUSIONS: Metabolic syndrome, but not obesity, defined by a BMI ≥30, was associated with wound complications, suggesting that metabolic effects of adiposity may represent a distinct risk factor in the development of wound complications from a higher BMI alone.

Proximal Versus Distal Continuous Adductor Canal Blocks: Does Varying Perineural Catheter Location Influence Analgesia? A Randomized, Subject-Masked, Controlled Clinical Trial.

BACKGROUND: A continuous adductor canal block provides analgesia after surgical procedures of the knee. Recent neuroanatomic descriptions of the thigh and knee led us to speculate that local anesthetic deposited in the distal thigh close to the adductor hiatus would provide superior analgesia compared to a more proximal catheter location. We therefore tested the hypothesis that during a continuous adductor canal nerve block, postoperative analgesia would be improved by placing the perineural catheter tip 2-3 cm cephalad to where the femoral artery descends posteriorly to the adductor hiatus (distal location) compared to a more proximal location at the midpoint between the anterior superior iliac spine and the superior border of the patella (proximal location). METHODS: Preoperatively, subjects undergoing total knee arthroplasty received an ultrasound-guided perineural catheter inserted either in the proximal or distal location within the adductor canal in a randomized, subject-masked fashion. Subjects received a single injection of lidocaine 2% via the catheter preoperatively, followed by an infusion of ropivacaine 0.2% (8 mL/h basal, 4 mL bolus, 30 minutes lockout) for the study duration. After joint closure, the surgeon infiltrated the entire joint using 30 mL of ropivacaine (0.5%), ketorolac (30 mg), epinephrine (5 µg/mL), and tranexamic acid (2 g). The primary end point was the median level of pain as measured on a numeric rating scale (NRS) during the time period of 8:00 AM to 12:00 PM the day after surgery. RESULTS: For the primary end point, the NRS of subjects with a catheter inserted at the proximal location (n = 24) was a median (10th, 25th-75th, 90th quartiles) of 0.5 (0.0, 0.0-3.2, 5.0) vs 3.0 (0.0, 2.0-5.4, 7.8) for subjects with a catheter inserted in the distal location (n = 26; P = .011). Median and maximum NRSs were lower in the proximal group at all other time points, but these differences did not reach statistical significance. There were no clinically relevant or statistically significant differences between the treatment groups for any other secondary end point, including opioid consumption and ambulation distance. CONCLUSIONS: For continuous adductor canal blocks accompanied by intraoperative periarticular local anesthetic infiltration, analgesia the day after knee arthroplasty is improved with a catheter inserted at the level of the midpoint between the anterior superior iliac spine and the superior border of the patella compared with a more distal insertion closer to the adductor hiatus.

Comparison of the iAssist Handheld Guidance System to Conventional Instruments for Mechanical Axis Restoration in Total Knee Arthroplasty.

BACKGROUND: Recent advances in total knee arthroplasty (TKA) include an intelligent instrument system designed to provide intraoperative guidance to reduce mechanical alignment errors. Internal position-sensing technology is integrated into microelectronic pods that attach to cutting blocks. The purpose of this prospective, randomized study was to determine whether this iAssist system enables the surgeon to make more accurate bone resections and better restore the mechanical axis compared to conventional instruments in TKA. METHODS: We randomized patients undergoing TKA into 2 groups. Group I (n = 25) underwent TKA assisted by the iAssist guidance system, group II (n = 25) underwent TKA using conventional instruments. Preoperative and postoperative mechanical axes were measured from full-length lower extremity radiographs to evaluate alignment. Additional surgical parameters were also assessed, including tourniquet time and blood loss. RESULTS: Patient demographics and preoperative mechanical axis alignments were similar between the groups. Postoperatively, 4.0% of patients had greater than 3° of tibial or femoral component mal-alignment in the guidance-assisted cohort, compared with 36.0% in the conventional group (P < .05). Additionally, group I showed significant improvement in variance seen in both the femoral mechanical axis (1.65° ± 0.17° vs 2.23° ± 0.33°, P < .005) and tibial mechanical axis (1.28° ± 0.13° vs 1.71° ± 0.24°, P < .005) compared to group II. There were no significant differences in tourniquet time (P = .86) or blood loss (P = .39) between groups. CONCLUSION: Use of the iAssist system in TKA results in an improved postoperative mechanical axis and decreased alignment variability compared to conventional instruments, without significantly increasing operative time.

Continuous Adductor Canal Versus Continuous Femoral Nerve Blocks: Relative Effects on Discharge Readiness Following Unicompartment Knee Arthroplasty.

BACKGROUND: We tested the hypothesis that, following unicompartment knee arthroplasty, a continuous adductor canal block decreases the time to reach 4 discharge criteria compared with a continuous femoral nerve block. METHODS: Subjects were randomized to either an adductor canal or femoral perineural catheter (2-day ropivacaine 0.2% infusion) in an unmasked fashion. The primary outcome was the time to attain 4 discharge criteria: (1) adequate analgesia; (2) intravenous opioid independence; (3) ability to independently stand, walk 3 m, return, and sit down; and (4) ambulate 30 m. RESULTS: Subjects with an adductor canal catheter (n = 15) reached all 4 criteria in a median of 35 hours (interquartile range, 24-43 hours), compared with 40 hours (interquartile range, 27-69 hours) for those with a femoral catheter (n = 15; Wilcoxon rank sum test: P = 0.46; log-rank test: P = 0.16). However, the percentages of subjects (adductor canal: femoral) who reached the 2 mobilization criteria were 27%:0% on postoperative day (POD) 0, 93%:53% on POD 1, and 100%:73% on POD 2. Of adductor canal subjects, 100% were discharge ready by POD 2, compared with only 73% of femoral subjects (P < 0.001). CONCLUSIONS: Compared with a continuous femoral nerve block, a continuous adductor canal block did not appreciably decrease the median number of hours to overall discharge readiness, yet did decrease the number of discrete days until discharge readiness. These results are applicable to only unicompartment knee arthroplasty and must be considered preliminary because of the limited sample size of this pilot study.

Discharge Readiness after Tricompartment Knee Arthroplasty: Adductor Canal versus Femoral Continuous Nerve Blocks-A Dual-center, Randomized Trial.

BACKGROUND: The authors conducted a randomized, controlled, parallel-arm, superiority study to test the hypothesis that a continuous adductor canal block decreases the time to attain four discharge criteria compared with a continuous femoral nerve block after tricompartment knee arthroplasty. METHODS: Subjects undergoing tricompartment knee arthroplasty were randomized using computer-generated lists to either an adductor canal or femoral perineural catheter (3-day ropivacaine 0.2% infusion) in an unmasked manner. The primary outcome was the time to attain four criteria: (1) adequate analgesia; (2) intravenous opioids independence; (3) ability to stand, walk 3 m, return, and sit down; and (4) ambulate 30 m. RESULTS: Subjects with an adductor canal catheter (n = 39) reached all four criteria in a median of 55 h (interquartile, 42 to 63 h) compared with 61 h (49 to 69 h) for those with a femoral catheter (n = 41; 95% CI, -13 to 1 h; P = 0.12). The percentage of subjects who reached the two mobilization criteria on postoperative days 1 and 2 were 72 and 95% for those with an adductor canal catheter (n = 39), but only 27 and 76% in subjects with a femoral catheter (n = 41; both P < 0.001). Differences in pain scores at rest and intravenous opioid requirements were minimal, but femoral infusion improved dynamic analgesia (P = 0.01 to 0.02). CONCLUSION: Compared with a continuous femoral nerve block, a continuous adductor canal block did not appreciably decrease the time to overall discharge readiness even though it did decrease the time until adequate mobilization, primarily because both groups experienced similar analgesia and intravenous opioid requirements that--in most cases--exceeded the time to mobilization.