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临床试验/NCT07833930
NCT07833930招募中不适用

An Observational Study on Incidence and Clinical Characteristics of Breakthrough Pain Following Brachial Plexus Block in Adult Patients With Diabetes Mellitus

Second Hospital of Shanxi Medical University1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2025年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
216
试验地点
1
主要终点
Incidence of postoperative rebound-breakthrough pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

结局指标

主要结局

Incidence of postoperative rebound-breakthrough pain

时间窗: Within 48 hours after brachial plexus block

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.

次要结局

  • Within 48 hours after brachial plexus block(Within 48 hours after block)
  • Onset time of first rebound-breakthrough pain(Within 48 hours after block)
  • Frequency of rebound-breakthrough pain episodes(Within 48 hours after block)
  • Duration of each rebound-breakthrough pain episode(Within 48 hours after block)

研究者

发起方
Second Hospital of Shanxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zheng Guo

Professor

Second Hospital of Shanxi Medical University

研究点 (1)

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