Incidence and Clinical Features of Breakthrough Pain After Brachial Plexus Block in Diabetic Patients
An Observational Study on Incidence and Clinical Characteristics of Breakthrough Pain Following Brachial Plexus Block in Adult Patients With Diabetes Mellitus
This observational study aims to determine the incidence and clinical characteristics of rebound-breakthrough pain after ultrasound-guided brachial plexus block in adult patients with type 2 diabetes mellitus. Adult patients undergoing elective upper-extremity surgery are divided into a type 2 diabetes group and a non-diabetic control group. Baseline clinical data and pain-related outcomes are collected after nerve block. This work may provide evidence for optimizing perioperative pain management for diabetic patients receiving brachial plexus block.
研究概览
地位
条件
详细说明
Background: Diabetes mellitus is a highly prevalent chronic disease worldwide. Diabetic peripheral neuropathy is one of its common complications, which may alter peripheral nerve function and pain perception. Brachial plexus block is widely used for upper-limb surgery. Rebound-breakthrough pain is a clinically important adverse event after peripheral nerve block, which worsens postoperative recovery and increases opioid consumption. The incidence and clinical features of this pain among patients with type 2 diabetes remain unclear.
This observational study enrolls adult patients undergoing elective upper-extremity surgery with ultrasound-guided brachial plexus block. Participants are separated into two groups: patients with type 2 diabetes mellitus and patients without diabetes. All patients receive routine clinical anesthesia with 0.375% ropivacaine for brachial plexus block without any experimental intervention. Pre-operative baseline information includes demographic data, glycosylated hemoglobin, diabetic history, and sensory threshold measurement. Post-block data including pain scores, onset and recovery time of sensory-motor block, patient-controlled analgesia usage and additional analgesic consumption are recorded.
The primary objective is to calculate the incidence of postoperative breakthrough-rebound pain. Secondary objectives cover pain severity, onset and duration of breakthrough pain, and perioperative analgesic consumption. Collected data will be summarized and analyzed to describe clinical characteristics associated with breakthrough pain.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Wen bo Wang
- 电话号码:+8618636532676
- 邮箱:1525565253@qq.com
学习地点
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Taiyuan、中国
- 招聘中
- Second Hospital of Shanxi Medical University
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接触:
- Zheng Guo
- 电话号码:+863513365790
- 邮箱:guozheng713@yahoo.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adult patients receiving ultrasound-guided brachial plexus block for elective upper-extremity surgery. Subjects are divided into two cohorts: patients with type 2 diabetes mellitus and non-diabetic patients. Routine clinical anesthesia management is adopted without experimental interventions.
描述
Inclusion Criteria:
- Aged 18 years or older
- Undergoing elective upper-extremity surgery
- Planned for ultrasound-guided brachial plexus block with 0.375% ropivacaine
- Able to cooperate with pain assessment and follow-up within 48 hours after block
- Written informed consent obtained
Exclusion Criteria:
- Allergy or contraindication to amide-type local anesthetics
- Pre-existing peripheral neuropathy of the affected upper limb
- Chronic regular use of opioids before surgery
- Coagulopathy or infection at the block puncture site
- Cognitive dysfunction unable to complete NRS pain evaluation
- Pregnancy or lactation
- Incomplete clinical data expected during follow-up
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:CROSS_SECTIONAL
队列和干预
团体/队列 |
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Patients with type 2 diabetes mellitus
Adult patients diagnosed with type 2 diabetes mellitus undergoing elective upper-extremity surgery with ultrasound-guided brachial plexus block. All subjects receive routine clinical anesthesia with 0.375% ropivacaine without experimental intervention. |
|
Patients without diabetes mellitus
Adult non-diabetic patients undergoing elective upper-extremity surgery with ultrasound-guided brachial plexus block. All subjects receive routine clinical anesthesia with 0.375% ropivacaine without experimental intervention. |
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 |
|---|---|---|
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Incidence of postoperative rebound-breakthrough pain
大体时间:Within 48 hours after brachial plexus block
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Proportion of participants developing rebound-breakthrough pain within 48 hours after brachial plexus block.Rebound-breakthrough pain after peripheral nerve block is characterized by sudden severe pain (NRS ≥ 7) occurring within 24 hours after block resolution. It is typically burning in nature, may occur at rest or during movement, lasts more than 2 hours, and most frequently develops 12-24 hours postoperatively. |
Within 48 hours after brachial plexus block
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Within 48 hours after brachial plexus block
大体时间:Within 48 hours after block
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Peak numerical rating scale (NRS, 0-10) score during each rebound-breakthrough pain episode. Higher score indicates more severe pain. |
Within 48 hours after block
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Onset time of first rebound-breakthrough pain
大体时间:Within 48 hours after block
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Time interval from completion of brachial plexus block to the first occurrence of rebound-breakthrough pain. |
Within 48 hours after block
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Frequency of rebound-breakthrough pain episodes
大体时间:Within 48 hours after block
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Total number of rebound-breakthrough pain episodes within 48 hours after brachial plexus block. |
Within 48 hours after block
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Duration of each rebound-breakthrough pain episode
大体时间:Within 48 hours after block
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Duration of each rebound-breakthrough pain episode that occurs within 48 hours after brachial plexus block. |
Within 48 hours after block
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合作者和调查者
调查人员
- 研究主任:Li li Wang、Second Hospital of Shanxi Medical University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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