PDF(Pubmed)
Abstract：
BACKGROUND: Obese patients undergoing laparoscopic sleeve gastrectomy (LSG) are particularly at risk of opioid-related side effects. To reduce patient exposure to opioids, multimodal analgesia, which involves the use of drugs of different classes, may be utilized. One of the drugs under consideration is pregabalin. Despite an opioid-sparing potential, few studies assess the role of pregabalin as an element of multimodal analgesia in LSG. Considering the limited number and inconsistent results of available studies, we decided to conduct a randomized, prospective study on the effect of preemptive pregabalin administration in obese patients on opioid consumption, pain scores, the incidence of opioid side effects, and hemodynamical stability.
METHODS: The study is designed as a prospective randomized controlled trial with double-blinding. Randomization will be performed in a block with a parallel 1:1 allocation. The intervention will involve receiving a pregabalin 150 mg capsule 1-2 h before the surgery, whereas the control group will receive an identically looking placebo. The primary outcome measure will be total oxycodone consumption in the first 24 h following surgery. Secondary outcome measures will be pain severity assessed using the Numerical Rating Scale (NRS) 1, 6, 12, and 24 h after surgery, postoperative sedation on the Ramsay scale, PONV impact scale, the incidence of desaturation episodes < 94%, and episodes of blurred vision at 1, 6, 12, and 24 h after surgery, intraoperative hemodynamic parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), total fluid volume, and total ephedrine dose. Patient comfort will be additionally assessed using the QoR-40 questionnaire at discharge.
CONCLUSIONS: The study will explore the efficacy and safety of preemptive pregabalin in a dose of 150 mg as a co-analgesic used in multimodal analgesia for LSG. As studies on opioid-sparing regimes concern the safety of obese patients, we aim to contribute objective data with a relatively large study sample size. The result of the present clinical trial may support the reassessment of recommendations to use pregabalin in the studied population.
BACKGROUND: ClinicalTrials.gov NCT05804591. Registered on 07.04.2023.
METHODS: The study is designed as a prospective randomized controlled trial with double-blinding. Randomization will be performed in a block with a parallel 1:1 allocation. The intervention will involve receiving a pregabalin 150 mg capsule 1-2 h before the surgery, whereas the control group will receive an identically looking placebo. The primary outcome measure will be total oxycodone consumption in the first 24 h following surgery. Secondary outcome measures will be pain severity assessed using the Numerical Rating Scale (NRS) 1, 6, 12, and 24 h after surgery, postoperative sedation on the Ramsay scale, PONV impact scale, the incidence of desaturation episodes < 94%, and episodes of blurred vision at 1, 6, 12, and 24 h after surgery, intraoperative hemodynamic parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), total fluid volume, and total ephedrine dose. Patient comfort will be additionally assessed using the QoR-40 questionnaire at discharge.
CONCLUSIONS: The study will explore the efficacy and safety of preemptive pregabalin in a dose of 150 mg as a co-analgesic used in multimodal analgesia for LSG. As studies on opioid-sparing regimes concern the safety of obese patients, we aim to contribute objective data with a relatively large study sample size. The result of the present clinical trial may support the reassessment of recommendations to use pregabalin in the studied population.
BACKGROUND: ClinicalTrials.gov NCT05804591. Registered on 07.04.2023.
摘要：
背景：接受腹腔镜袖状胃切除术（LSG）的肥胖患者尤其面临阿片类药物相关副作用的风险。为了减少患者接触阿片类药物，多模式镇痛,涉及使用不同类别的药物，可以利用。正在考虑的药物之一是普瑞巴林。尽管有保留阿片类药物的潜力，很少有研究评估普瑞巴林作为多模式镇痛在LSG中的作用。考虑到现有研究的数量有限且结果不一致，我们决定进行随机化，肥胖患者先发制人普瑞巴林给药对阿片类药物消耗影响的前瞻性研究，疼痛评分,阿片类药物副作用的发生率，和血液动力学稳定性。
方法：本研究设计为双盲前瞻性随机对照试验。随机化将在具有并行1:1分配的块中执行。干预将包括在手术前1-2小时接受普瑞巴林150毫克胶囊，而对照组将接受外观相同的安慰剂。主要结果指标将是手术后的前24小时内的羟考酮总消耗量。次要结果指标将是使用数字评定量表（NRS）在手术后1、6、12和24小时评估疼痛严重程度，Ramsay量表的术后镇静,PONV影响量表，去饱和发作的发生率<94%，以及术后1、6、12和24小时视力模糊的发作，术中血流动力学参数，如心率（HR），收缩压（SBP），舒张压（DBP），平均血压（MBP），总流体体积,和麻黄碱的总剂量。出院时将使用QoR-40问卷额外评估患者的舒适度。
结论：本研究将探讨150mg剂量的普瑞巴林作为联合镇痛药用于LSG的多模式镇痛的有效性和安全性。由于对阿片类药物保留方案的研究关注肥胖患者的安全性，我们的目标是提供相对较大的研究样本量的客观数据。本临床试验的结果可能支持重新评估在研究人群中使用普瑞巴林的建议。
背景：ClinicalTrials.govNCT05804591。07.04.2023年注册。
方法：本研究设计为双盲前瞻性随机对照试验。随机化将在具有并行1:1分配的块中执行。干预将包括在手术前1-2小时接受普瑞巴林150毫克胶囊，而对照组将接受外观相同的安慰剂。主要结果指标将是手术后的前24小时内的羟考酮总消耗量。次要结果指标将是使用数字评定量表（NRS）在手术后1、6、12和24小时评估疼痛严重程度，Ramsay量表的术后镇静,PONV影响量表，去饱和发作的发生率<94%，以及术后1、6、12和24小时视力模糊的发作，术中血流动力学参数，如心率（HR），收缩压（SBP），舒张压（DBP），平均血压（MBP），总流体体积,和麻黄碱的总剂量。出院时将使用QoR-40问卷额外评估患者的舒适度。
结论：本研究将探讨150mg剂量的普瑞巴林作为联合镇痛药用于LSG的多模式镇痛的有效性和安全性。由于对阿片类药物保留方案的研究关注肥胖患者的安全性，我们的目标是提供相对较大的研究样本量的客观数据。本临床试验的结果可能支持重新评估在研究人群中使用普瑞巴林的建议。
背景：ClinicalTrials.govNCT05804591。07.04.2023年注册。
