Cerchione Claudio, Martinelli Giovanni, Picardi Marco, Pugliese Novella, Nappi Davide, Casoria Aniello, Gravetti Angela, Cangini Delia, Giannini Maria Benedetta, Ronconi Sonia, Simonetti Giorgia, Ghelli Luserna Di Rorà Andrea, De Giorgi Ugo, Altini Mattia, Bravaccini Sara, Santoriello Ilaria, Minucci Cristiano, Pane Fabrizio, Martinelli Vincenzo
Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, 47014 Meldola, Italy.
Hematology, Department of Clinical Medicine and Surgery, AOU Federico II, 80131 Naples, Italy.
J Clin Med. 2020 Feb 1;9(2):395. doi: 10.3390/jcm9020395.
Bone marrow aspiration and biopsy (BMAB) is a painful procedure, and the routinely used local infiltration anesthesia (LIA) with lidocaine is unable to provide pain relief during the most uncomfortable phases. The primary endpoint of the present randomized, patient-blinded trial was to evaluate the efficacy of an opioid and benzodiazepine combination plus LIA (sedoanalgesia) in patients undergoing BMAB for hematological malignancies. The secondary endpoint was the safety of the procedure in an outpatient setting. Ancillary assessments were anticipatory anxiety related to pain recall in the event of re-biopsy, and adequacy of bone tissue harvested. Patients were randomly assigned to one of 2 arms to receive either sedoanalgesic placebo plus LIA (standard group) or oral fentanyl citrate 200 μg plus oral midazolam 5 mg plus LIA (combo group) during BMAB. Pre-procedural anxiety and procedural pain were assessed according to the Numerical Rating Scale (NRS: 0-10), dividing the time of the procedure into five intervals (T0, T1, T2a, T2b and T3) and evaluating the degree of discomfort at each time (T) in both groups. One hundred and sixteen patients were eligible for the study. At T2b (time of biopsy) and T3 (time after biopsy), a significantly lower perception of pain was registered in the combo group. Moreover, there were no significant sedoanalgesia-related side-effects. Finally, histological specimens were higher in quality in the combo group. Sedoanalgesia was highly effective in reducing pain during biopsy, diminished anticipatory anxiety in patients undergoing re-biopsy and led to fewer non-diagnostic specimens being harvested.
骨髓穿刺活检（BMAB）是一种痛苦的操作，常规使用的利多卡因局部浸润麻醉（LIA）在最不适阶段无法缓解疼痛。本随机、患者盲法试验的主要终点是评估阿片类药物和苯二氮䓬类药物联合LIA（镇静镇痛）在因血液系统恶性肿瘤接受BMAB的患者中的疗效。次要终点是该操作在门诊环境中的安全性。辅助评估包括再次活检时与疼痛回忆相关的预期焦虑，以及采集骨组织的充分性。患者被随机分配到两个组之一，在BMAB期间接受镇静镇痛安慰剂加LIA（标准组）或口服200μg枸橼酸芬太尼加口服5mg咪达唑仑加LIA（联合组）。根据数字评分量表（NRS：0 - 10）评估术前焦虑和操作疼痛，将操作时间分为五个时间段（T0、T1、T2a、T2b和T3），并评估两组在每个时间点（T）的不适程度。116名患者符合研究条件。在T2b（活检时）和T3（活检后），联合组的疼痛感知明显较低。此外，没有明显的镇静镇痛相关副作用。最后，联合组的组织学标本质量更高。镇静镇痛在减少活检期间的疼痛、减轻再次活检患者的预期焦虑以及减少非诊断性标本采集方面非常有效。
