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.
연구 개요
상태
상태
정황
정황
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Wen bo Wang
- 전화번호: +8618636532676
- 이메일: 1525565253@qq.com
연구 장소
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Taiyuan, 중국
- 모병
- Second Hospital of Shanxi Medical University
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연락하다:
- Zheng Guo
- 전화번호: +863513365790
- 이메일: guozheng713@yahoo.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: CROSS_SECTIONAL
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of postoperative rebound-breakthrough pain
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Within 48 hours after brachial plexus block
기간: 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
기간: Within 48 hours after block
|
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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Li li Wang, Second Hospital of Shanxi Medical University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- [2025]YX277
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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