Reducing Postoperative Opioid Consumption by Adding Transdermal Fentanyl Patches to Multimodal Analgesia after Breast Cancer Surgery

M. Mf, Othman Ah, Darwish Amm, Elzohry Aam
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Abstract

Background: Breast surgeries are among the common forms of surgeries that conducted daily in hospitals. Multimodal analgesia, which combines analgesics with variable pharmacodynamics to target multiple underlying mechanisms of pain, is evolving as an acceptable approach to pain treatment for acute pain. So Transdermal fentanyl patch (TDF) can ameliorate severe pain in breast surgery. Objective: To examine the efficacy and safety of adding Transdermal fentanyl patch (TDF) to multimodal analgesia in controlling acute postoperative pain after breast surgery if applied 12 hours prior surgery. Methods: This randomized, blinded, study was conducted after approval of local ethics committee of South Egypt Cancer Institute, Assiut University, Assiut–Egypt, and registered at www.clinicaltrials.gov at no.: “NCT03051503”. After obtaining written informed consent, Sixty four adult female patients (ASA II) were scheduled for elective breast cancer surgeries in the form of modified radical mastectomy. Patients were classified randomly into two groups (32 patients each) to receive beside standard GA, Transdermal fentanyl patch (TDF) 50 μg/hr applied 12 hours prior surgery in one group (TDF group), while the second group (control group) received standard GA alone. Both group treated by morphine PCA for postoperative pain. Visual analogue scale (VAS), side effects, and serum levels of cortisol and prolactin were assessed over 24 h. postoperatively. The intra and post-operative heart rate (HR) and mean arterial pressure (MAP), Ramsay sedation score and total morphine consumption via PCA postoperatively were also recorded. Results: MAP and heart rate during intra and early post-operative periods were significantly reduced in TDF group in comparison to control group (P ≤ 0.005) but not over the remaining post-operative period (P>0.01). And, there was significant decrease in both VAS scores (p<0.05) and hence the total amount of morphine consumed postoperatively (7.43 ± 4.39) in TDF group in comparison to control group (13.47 ± 4.73) without significant change in side effects, except sedation scores, which were statistically increased but clinically not effective, in early post-operative hours. Finally, levels of prolactin and cortisol hormones were significantly decreased in TDF group indicating less stress and better pain control. Conclusion: Applying Transdermal fentanyl patch (TDF) 50 μg/hr 12 hours prior surgery as a part of multimodal analgesia to control acute postoperative pain after modified radical mastectomy was associated with less stress response, better pain control and decreased total amount of postoperative morphine consumption.
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乳腺癌术后多模式镇痛中加入经皮芬太尼贴片减少阿片类药物的使用
背景:乳房手术是医院日常进行的常见手术形式之一。多模态镇痛是一种结合了不同药效学的镇痛药物来针对多种潜在的疼痛机制的镇痛方法,它正在发展成为一种治疗急性疼痛的可接受的方法。因此,芬太尼透皮贴片(TDF)可以改善乳房手术的严重疼痛。目的:探讨芬太尼透皮贴片(TDF)在多模式镇痛中应用于乳房手术术后12小时急性疼痛的疗效和安全性。方法:本随机、盲法研究经Assiut - Egypt University南埃及癌症研究所当地伦理委员会批准后进行,注册账号为www.clinicaltrials.gov,注册号为0。:“NCT03051503”。在获得书面知情同意后,64名成年女性患者(ASA II)被安排以改良乳房根治术的形式进行选择性乳腺癌手术。将患者随机分为两组(每组32例),除标准GA外,另一组(TDF组)术前12 h涂敷50 μg/hr的芬太尼透皮贴剂(TDF),另一组(对照组)单独涂敷标准GA。两组均采用吗啡PCA治疗术后疼痛。术后24小时评估视觉模拟评分(VAS)、副作用、血清皮质醇和催乳素水平。记录患者术中、术后心率(HR)、平均动脉压(MAP)、Ramsay镇静评分及术后PCA吗啡总用量。结果:与对照组相比,TDF组术中及术后早期MAP、心率明显降低(P≤0.005),术后剩余时间无明显降低(P>0.01)。两组VAS评分均显著降低(p<0.05), TDF组术后吗啡总用量(7.43±4.39)较对照组(13.47±4.73)显著降低(p<0.05),除镇静评分术后早期有统计学升高但临床无效外,其他不良反应无显著变化。最后,TDF组催乳素和皮质醇水平显著降低,表明应激减轻,疼痛控制较好。结论:手术前12小时应用芬太尼透皮贴剂(TDF) 50 μg/hr作为多模式镇痛的一部分控制改良乳房根治术术后急性疼痛,应激反应减轻,疼痛控制较好,术后吗啡总用量减少。
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