Lau Wei C, Shannon Francis L, Bolling Steven F, Romano Matthew A, Sakwa Marc P, Trescot Andrea, Shi Luoxi, Johnson Robert L, Starnes Vaughn A, Grehan John F
William Beaumont Hospital, 3601 West 13 Mile Road, Royal Oak, MI, 48703, USA.
University of Michigan, Ann Arbor, MI, USA.
Pain Ther. 2021 Dec;10(2):1579-1592. doi: 10.1007/s40122-021-00318-0. Epub 2021 Sep 20.
Intercostal cryo nerve block has been shown to enhance pulmonary function recovery and pain management in post-thoracotomy procedures. However, its benefit have never been demonstrated in minimal invasive thoracotomy heart valve surgery (Mini-HVS). The purpose of the study was to determine whether intraoperative intercostal cryo nerve block in conjunction with standard of care (collectively referred to hereafter as CryoNB) provided superior analgesic efficacy in patients undergoing Mini-HVS compared to standard-of-care (SOC).
FROST was a prospective, 3:1 randomized (CryoNB vs. SOC), multicenter trial in patients undergoing Mini-HVS. The primary endpoint was the 48-h postoperative forced expiratory volume in 1 s (FEV1) result. Secondary endpoints were visual analog scale (VAS) scores for pain at the surgical site and general pain, intensive care unit and hospital length-of-stay, total opioid consumption, and allodynia at 6 months postoperatively.
A total of 84 patients were randomized to the two arms of the trial CryoNB (n = 65) and SOC (n = 19). Baseline Society of Thoracic Surgeons Predictive Risk of Mortality (STS PROM) score, ejection fraction, and FEV1 were similar between cohorts. A higher 48-h postoperative FEV1 result was demonstrated in the CryoNB cohort versus the SOC cohort (1.20 ± 0.46 vs. 0.93 ± 0.43 L; P = 0.02, one-sided two-sample t test). Surgical site VAS scores were similar between the CryoNB and SOC cohorts at all postoperative timepoints evaluated, but VAS scores not related to the surgical site were lower in the SOC group at 72, 94, and 120 h postoperatively. The SOC cohort had a 13% higher opioid consumption than the CryoNB cohort. One of 64 CryoNB patients reported allodynia that did not require pain medication at 10 months.
The results of FROST demonstrated that intercostal CryoNB provided enhanced FEV1 score at 48 h postoperatively with optimized analgesic effectiveness versus SOC. Future larger prospective randomized trials are warranted to determine whether intercostal CryoNB has an opioid-sparing effect in patients undergoing Mini-HVS.
Clinicaltrials.gov identifier: NCT02922153.
肋间冷冻神经阻滞已被证明可促进开胸手术后的肺功能恢复并改善疼痛管理。然而，其在微创开胸心脏瓣膜手术（Mini-HVS）中的益处尚未得到证实。本研究的目的是确定与标准治疗（以下统称为冷冻神经阻滞[CryoNB]）相比，术中肋间冷冻神经阻滞联合标准治疗在接受Mini-HVS的患者中是否具有更好的镇痛效果。
FROST是一项针对接受Mini-HVS患者的前瞻性、3:1随机分组（CryoNB组与标准治疗组[SOC]）、多中心试验。主要终点是术后48小时的1秒用力呼气量（FEV1）结果。次要终点包括手术部位疼痛和全身疼痛的视觉模拟量表（VAS）评分、重症监护病房和住院时间、总阿片类药物消耗量以及术后6个月的异常性疼痛。
共有84例患者被随机分为试验的两组，CryoNB组（n = 65）和SOC组（n = 19）。两组患者的基线胸外科医师协会死亡率预测风险（STS PROM）评分、射血分数和FEV1相似。与SOC组相比，CryoNB组术后48小时的FEV1结果更高（1.20±0.46 vs. 0.93±0.43 L；P = 0.02，单侧双样本t检验）。在所有评估的术后时间点，CryoNB组和SOC组的手术部位VAS评分相似，但术后72、94和120小时，SOC组与手术部位无关的VAS评分较低。SOC组的阿片类药物消耗量比CryoNB组高13%。64例CryoNB患者中有1例在10个月时报告了无需使用止痛药物的异常性疼痛。
FROST研究结果表明，与SOC相比，肋间CryoNB在术后48小时可提高FEV1评分，并具有优化的镇痛效果。未来有必要进行更大规模的前瞻性随机试验，以确定肋间CryoNB在接受Mini-HVS的患者中是否具有阿片类药物节省效应。
Clinicaltrials.gov标识符：NCT02922153。
