目的:验证度洛西汀降低结肠大手术患者术后吗啡用量和疼痛强度的假设。
方法:单中心,prospective,双盲,随机化,对照试验。
方法:大学附属医院,从2019年12月到2021年9月。
方法:60岁18-85岁,接受择期开放大结肠手术的ASAI-III患者随机分为度洛西汀(度洛西汀)组或安慰剂(安慰剂)组(每组n=30)。
方法:在手术前2小时和手术后24小时口服度洛西汀60mg或安慰剂。
方法:PCA吗啡消耗,休息时的手术疼痛,以及在10厘米视觉模拟量表(VAS)上测量的运动,Ramsay镇静评分,在患者进入麻醉后监护病房(PACU)时,评估可能与度洛西汀相关的不良反应的发生率,术后6、24和48小时(PO)。
结果:调整年龄后,BMI,ASA物理状态,教育水平,和切口类型,PCA吗啡消耗24POh组间无差异(度洛西汀=5.44±2.06mg;安慰剂=10.33±2.06mg,p=0.62)或48hPO(度洛西汀=9.18±2.06mg,安慰剂=12.93±2.06,p=1)。在24hPO时,静息时的疼痛在两组之间也没有差异(度洛西汀=1.76±0.67cm;安慰剂=1±0.67cm,p=1)或在48hPO(度洛西汀=0.84±0.67cm;安慰剂=0.49±0.67cm,p=1)。同样,在24hPO时(度洛西汀=2.09±0.68cm;安慰剂=1.80±0.68,p=1)或48hPO时(度洛西汀=1.16±0.68cm;安慰剂=0.88±0.68cm,p=1)。两组之间的镇静评分和不良反应也没有差异。
结论:在本研究的条件下,在大结肠手术后的最初48小时内,短期度洛西汀并未降低阿片类药物的总消耗量或疼痛强度.
OBJECTIVE: To test the hypothesis that duloxetine reduces postoperative morphine consumption and pain intensity in patients undergoing major colonic surgeries.
METHODS: Single-center, prospective, double-blinded, randomized, controlled
trial.
METHODS: Tertiary university hospital, from December 2019 to September 2021.
METHODS: Sixty 18-85 years old, ASA I - III patients undergoing elective open major colonic surgeries were randomly allocated into duloxetine (duloxetine) or placebo (placebo) groups (n = 30 per group).
METHODS: Duloxetine 60 mg or placebo was administered orally 2 h before and 24 h after surgery.
METHODS: PCA morphine consumption, surgical pain at rest, and movement measured on 10-cm visual analog scales (VAS), Ramsay sedation scores, and the incidence of adverse effects potentially associated with duloxetine were assessed at patients\' admission to the post-anesthesia care unit (PACU), 6, 24, and 48 h postoperatively (PO).
RESULTS: After adjusting for age, BMI, ASA physical status, education level, and incision type, no differences were found between groups in PCA morphine consumption 24 PO h (duloxetine = 5.44 ± 2.06 mg; placebo = 10.33 ± 2.06 mg, p = 0.62) or 48 h PO (duloxetine = 9.18 ± 2.06 mg, placebo = 12.93 ± 2.06, p = 1). Pain at rest also did not differ between groups at 24 h PO (duloxetine = 1.76 ± 0.67 cm; placebo = 1 ± 0.67 cm, p = 1) or at 48 h PO (duloxetine = 0.84 ± 0.67 cm; placebo = 0.49 ± 0.67 cm, p = 1). Similarly, groups did not differ regarding pain on movement at 24 h PO (duloxetine = 2.09 ± 0.68 cm; placebo = 1.80 ± 0.68, p = 1) or at 48 h PO (duloxetine = 1.16 ± 0.68 cm; placebo = 0.88 ± 0.68 cm, p = 1). Sedation scores and adverse effects also did not differ between groups.
CONCLUSIONS: Under this
study\'s conditions, short-term duloxetine did not reduce total opioid consumption or pain intensity during the initial 48 h following major colon surgery.