METHODS: We conducted a placebo-controlled, patient-, surgeon-, and assessor-blinded, randomized controlled trial at a single center between June 2022 and July 2023 including 321 adult patients undergoing open AWR with retromuscular mesh. Patients received noise-canceling headphones and were randomized 1:1 to patient-selected music or silence after induction, stratified by preoperative chronic opioid use. All patients received multimodal pain control. The primary outcome was pain (NRS-11) at 24 ± 3 h. The primary outcome was analyzed by linear regression with pre-specified covariates (chronic opioid use, hernia width, operative time, myofascial release, anxiety disorder diagnosis, and preoperative STAI-6 score).
RESULTS: 178 patients were randomized to music, 164 of which were analyzed. 177 were randomized to silence, 157 of which were analyzed. At 24 ± 3 h postoperatively, there was no difference in the primary outcome of NRS-11 scores (5.18 ± 2.62 vs 5.27 ± 2.46, p = 0.75). After adjusting for prespecified covariates, the difference of NRS-11 scores at 24 ± 3 h between the music and silence groups remained insignificant (p = 0.83). There was no difference in NRS-11 or STAI-6 scores at 48 ± 3 and 72 ± 3 h, intraoperative sedation, or postoperative narcotic usage.
CONCLUSIONS: For patients undergoing AWR, there was no benefit of intraoperative music over routine multimodal pain control for early postoperative pain reduction.
BACKGROUND: ClinicalTrials.gov: NCT05374096.
方法:我们进行了安慰剂对照,患者-,外科医生-,评估员失明,2022年6月至2023年7月在一个单中心进行的随机对照试验,包括321例接受开放AWR并带后肌网的成年患者.患者接受降噪耳机,并在诱导后1:1随机分配给患者选择的音乐或静音,按术前长期使用阿片类药物进行分层。所有患者均接受多模式疼痛控制。主要结果是24±3h的疼痛(NRS-11)。通过使用预先指定的协变量(慢性阿片类药物使用,疝宽度,手术时间,肌筋膜释放,焦虑症诊断,和术前STAI-6评分)。
结果:178名患者被随机分配到音乐,其中164份进行了分析。177人被随机分配到沉默,其中157个进行了分析。术后24±3小时,NRS-11评分的主要结局无差异(5.18±2.62vs5.27±2.46,p=0.75)。在调整了预先指定的协变量后,音乐组和沉默组之间在24±3小时的NRS-11得分差异不明显(p=0.83)。在48±3和72±3h时,NRS-11或STAI-6评分无差异,术中镇静,或术后麻醉剂的使用。
结论:对于接受AWR的患者,对于术后早期疼痛减轻,术中音乐对常规多模式疼痛控制没有益处.
背景:ClinicalTrials.gov:NCT05374096。