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The Effect of Intravenous Dexketoprofen on the Severity and Incidence of Rebound Pain

2026年6月11日 更新者:Çağla Uzalp、Eskisehir Osmangazi University

Evaluation of the Effect of Intravenous Dexketoprofen on the Severity and Incidence of Rebound Pain in Patients Undergoing Interscalene Brachial Plexus Block

Orthopedic shoulder surgeries are associated with severe postoperative pain, particularly within the first 24-48 hours after surgery. In postoperative pain management, single or continue interscalene brachial plexus blocks, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids administered as needed are commonly used as components of multimodal analgesia.

Rebound pain is defined as severe postoperative pain (VAS ≥ 7) occurring within the first 24 hours after resolution of the block. It is considered an adverse effect of regional anesthesia and typically develops 8-12 hours after a single-shot nerve block. Risk factors for rebound pain include pre-existing pain, female sex, younger age, bone surgery, lack of intraoperative dexamethasone administration, and inadequate analgesia.

The primary objective of this study is to evaluate the effect of intravenous dexketoprofen administered during the postoperative period on the incidence and severity of rebound pain in patients undergoing shoulder surgery with interscalene brachial plexus block

研究概览

详细说明

Sixty-six patients undergoing rotator cuff repair will receive standardized ISB and general anesthesia for the surgery.All patients will be administered 0.03 mg/kg of midazolam during the preoperative period and an interscalene brachial plexus block will be administered using 10 cc of %0.5 bupivacaine and 5 ml of normal saline.During induction under general anesthesia, the following will be administered: lidocaine 1 mg/kg, propofol 2-3 mg/kg, rocuronium 0.6 mg/kg, and remifentanyl 0.5 mcg/kg. Maintenance of anesthesia will be provided using a mixture of %2-3 sevoflurane, %50 air, and %50 oxygen, maintaining the bispectral index between 40 and 50.

Heart rate and blood pressure values will be titrated by increasing or decreasing the remifentanil infusion to ensure that the values remain within %20 of baseline or that the OAB remains above 65.

If the mean arterial pressure drops by more than %20, 5 mg of ephedrine will be administered.

At the end of the procedure, the surgical duration and the total intraoperative remifentanil dose administered will be recorded.

In the postoperative recovery room, patients who show no loss of sensation in the C5-C6 dermatome (over the deltoid muscle) on the pinprick test but report severe pain (VAS ≥ 4) will be considered to have had a failed block.

Under the postoperative analgesia protocol all patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time and all patients will be administered 1 gram of paracetamol at 8th 16th and 24th hours.

Patients will be randomly divided into 2 groups as Group K(Patients not receiving nonsteroidal anti-inflammatory drugs) and Group D(Patients receiving nonsteroidal anti-inflammatory drugs) In Group D (Patients receiving nonsteroidal anti-inflammatory drugs) cases, will be administered 25 miligram of dexketroprofen at 6th and 18th hours.

In the postoperative period, a researcher assessed the patient's visual pain scores (resting and movement), rebound pain intensity, timing, and duration, systolic blood pressure, mean arterial pressure, diastolic blood pressure, peripheral oxygen saturation, postoperative analgesic consumption, and postoperative complications will be recorded.

Patient follow-up will be concluded at the end of 24 hours.

研究类型

介入性

注册 (估计的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Odunpazarı
      • Eskişehir、Odunpazarı、土耳其(türkiye)、26040
        • 招聘中
        • Eskisehir Osmangazi Universıty Faculty of Medicine
        • 接触:
        • 接触:
        • 首席研究员:
          • Çağla Uzalp

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Age 18-70 years ASA score of I-III Arthroscopic shoulder surgery

Exclusion Criteria:

Patients who do not wish to participate in the study Creatinine clearance <50 mL/ min Patients for whom NSAID use is contraindicated due to heart failure, Patients with psychiatric or cognitive dysfunction that would impair their ability to assess visual analog scale (VAS) pain scores Patients for whom peripheral nerve block is contraindicated

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:Group K
Under the postoperative analgesia protocol all patients will be administered 1 gr of paracetamol at 8th 16th and 24th hours and all patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device.
ISB + paracetamol IV 3*1
有源比较器:Group D
Under the postoperative analgesia protocol all patients will be administered 1 gram of paracetamol at 8th 16th and 24th hours and all patients receiving nonsteroidal anti-inflammatory drugs (25 miligram of dexketroprofen) at 6th and 18th hours. The patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device.
ISB+ paracetamol IV 3*1 +deksketoprofen IV 2*1. 25 miligram of dexketroprofen

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Effect of intravenous dexketoprofen administered during the postoperative period on the severity and incidence of rebound pain
大体时间:24 hours
Rebound pain score(VAS ≥ 7) and incidence
24 hours

次要结果测量

结果测量
措施说明
大体时间
Total opioid consumption
大体时间:24 hours
Total morphine patient control analgesia prepared 0.5 mg / ml. PCA 1 mg bolus dose will be delivered with 10 min lock-out time. Follow up morphine consumption at postoperative 24 hours
24 hours
Visual analog Scale
大体时间:24 hours
Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))
24 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:MERYEM ONAY、Eskisehir Osmangazi University Faculty Of Medıcıne

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月11日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月11日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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