作者
X H Yu,Yi Yuan,Song Zhao,Sun Zhijian,Feng Han,S R Wang,Z Q Zhang,Sun Ke,Fangfang Duan,Yunyang Jia,Yinghong Ma,Ting Li
摘要
BACKGROUND: Hip fracture volumes are rising with population aging, and inadequate analgesia following hip fracture surgery has been shown to impede early mobilization and recovery. Liposomal bupivacaine (LB) may extend analgesia, but previous orthopaedic trials have yielded mixed results. We therefore tested whether adding local incisional infiltration of LB to multimodal analgesia confers clinically relevant advantages in geriatric hip fracture surgery. METHODS: This study was a single-center, prospective, randomized, participant and assessor-blinded, parallel-group exploratory trial in older adults undergoing hemiarthroplasty or total hip arthroplasty for a hip fracture. The intervention was local LB infiltration; the control was no local infiltration. The primary end point was resting pain measured on a visual analog scale (VAS, 0 to 10) at 48 hours postoperatively. Prespecified key secondary end points included early pain with activity, morphine milligram equivalents (MME) of the patient-controlled analgesia (PCA) infusion volume and of the total perioperative oral and intramuscular rescue counts, sleep quality measured on a numerical rating scale (NRS, 0 to 10), total sleep time, and nocturnal awakenings. RESULTS: A total of 76 patients (median age, 77 years; 49 female) were included in the analysis. The primary end point did not differ between the groups (median 0 for both; p = 0.143; point estimate of between-group difference: Cohen d = -0.506, 95% confidence interval: -0.962, -0.048), whereas several secondary outcomes significantly favored LB, including resting pain at 24 hours; activity pain at 8, 24, and 48 hours; and oral rescue administrations (median and interquartile range: 25 [0, 50] versus 50 [25, 100] MME). The LB group had a higher NRS sleep quality score after surgery, with a longer total sleep duration on the operative night, than the control group; the number of awakenings was similar between the groups. Ambulation at 48 and 72 hours and the number of postoperative days to discharge did not differ between the groups. CONCLUSIONS: In the context of a standardized multimodal analgesic pathway, local incisional infiltration of LB did not improve the prespecified primary end point of resting pain at 48 hours after geriatric hip fracture surgery. Overall, the current evidence does not support routine clinical use, and further investigation is warranted. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.