Background: The U.S. Food and Drug Administration has approved a bupivacaine and meloxicam extended-release (ER) intra-articular injection for pain during total knee arthroplasty (TKA). However, the real-world evidence with regard to analgesic efficacy of that medication has been limited. This randomized clinical trial investigated the efficacy of this new medication compared with our standard periarticular injection for postoperative analgesia after primary TKA. Methods: Eligible patients undergoing primary, unilateral TKA for osteoarthritis at our academic center were enrolled. Patients were blinded and were randomized 1:1 to the bupivacaine-meloxicam ER (ZYNRELEF) injection group or the standard injection (ropivacaine, ketorolac, epinephrine) control group. A standardized, multimodal analgesic pathway was implemented. Numeric Rating Scale (NRS) pain scores and tallies of opioid consumption were collected. The primary outcome was the area under the curve (AUC) for NRS pain, adjusted for opioid consumption, over 72 hours. The minimal clinically important difference was considered to be 30%. Power analysis determined a minimum of 44 patients per group. The final groups included 53 patients in the experimental group and 48 patients in the control group. Results: Similar postoperative analgesia was observed, with an AUC for the adjusted NRS pain score up to 72 hours of 331 in the experimental group and 373 in the control group (p = 0.09). The mean maximum NRS pain scores were similar and reflected good, but not complete, analgesia. Scores were 3 to 5 on the day of the surgery, 4 to 6 on postoperative day (POD) 1, 5 to 6 on POD 2, and 4 to 5 on POD 3 (p > 0.05). One patient in the experimental group and 2 patients in the control group had early postoperative complications, none of which was deemed to be related to the analgesic choice. Conclusions: This randomized clinical trial demonstrated similar analgesia with a bupivacaine-meloxicam ER solution and a standard periarticular injection up to 72 hours after primary TKA. Cost, reimbursement, and convenience may ultimately prove to be more important than analgesic differences when choosing between these 2 effective options for managing postoperative pain. Level of Evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
Prospective Noninvasive Hemoglobin Monitoring in the Outpatient Total Joint Arthroplasty Setting
Background: Total joint arthroplasty (TJA) is increasingly being performed as an outpatient (i.e., same-day discharge) procedure. Postoperatively, orthostatic hypotension or pain-related tachycardia can lead to concerns regarding the hemoglobin (Hgb) level of the patient prior to discharge. The purpose of this study was to prospectively assess the reliability and accuracy of, and patient and nurse satisfaction with, postoperative noninvasive hemoglobin (nHgb) monitoring compared with an invasive serum hemoglobin (iHgb) laboratory draw in the outpatient TJA setting. Methods: We prospectively enrolled 200 patients undergoing outpatient unilateral TJA, of whom 157 were ultimately included in our analysis (94 hips, 63 knees). Postoperatively, both nHgb and iHgb values were obtained at a mean of 36 minutes apart. Surveys were completed by patients and nurses. The strength of the agreement between the 2 Hgb monitoring methods was evaluated with use of the Bland-Altman 95% limits of agreement, concordance correlation coefficient (CCC), and intraclass correlation coefficient (ICC). Receiver operating characteristic curve analyses were performed to investigate the ability of nHgb monitoring to predict an iHgb of <11.2 g/dL (the 5th-percentile iHgb value). Results: The mean preoperative iHgb was 14.2 ± 1.1 g/dL. The mean postoperative iHgb and nHgb values were 13.3 ± 1.5 and 13.3 ± 1.2 g/dL, respectively. The Bland-Altman 95% limits of agreement were −3.2 and +3.1 g/dL, indicating that 95% of patients’ iHgb values are expected to fall between these limits relative to the nHgb value of the patient. The CCC and ICC were both 0.33. An nHgb cutoff value of <12.7 g/dL had 100% sensitivity and 67% specificity for detecting an iHgb of <11.2 g/dL. Patients reported less pain with the nHgb test than with the iHgb test (mean pain score, 0.0 versus 1.8; p < 0.001), and 97% of patients preferred the nHgb test. Following the nHgb test, 73% of responding patients and 83% of responding nurses were “somewhat more reassured” to “significantly more reassured” about same-day discharge. Conclusions: Routine nHgb testing can rapidly screen patients undergoing outpatient TJA for acute anemia prior to discharge. With an nHgb of <12.7 g/dL, there was perfect sensitivity and 67% specificity for detecting an iHgb of <11.2 g/dL. Most patients and nurses felt more reassured about same-day discharge after nHgb monitoring. Level of Evidence: Diagnostic Level II . See Instructions for Authors for a complete description of levels of evidence.