Incidence and Clinical Features of Breakthrough Pain After Brachial Plexus Block in Diabetic Patients

September 17, 2026 updated by: Zheng Guo, Second Hospital of Shanxi Medical University

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.

Study Overview

Status

Recruiting

Conditions

Postoperative Pain

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Wen bo Wang
Phone Number: +8618636532676
Email: 1525565253@qq.com

Study Locations

China
- - Taiyuan, China
    - Recruiting
    - Second Hospital of Shanxi Medical University
    - Contact:
      
      Zheng Guo
      
      Phone Number: +863513365790
      
      Email: guozheng713@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: COHORT
Time Perspectives: CROSS_SECTIONAL

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative rebound-breakthrough pain Time Frame: 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.	Within 48 hours after brachial plexus block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within 48 hours after brachial plexus block Time Frame: Within 48 hours after block	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
Onset time of first rebound-breakthrough pain Time Frame: 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
Frequency of rebound-breakthrough pain episodes Time Frame: Within 48 hours after block	Total number of rebound-breakthrough pain episodes within 48 hours after brachial plexus block.	Within 48 hours after block
Duration of each rebound-breakthrough pain episode Time Frame: Within 48 hours after block	Duration of each rebound-breakthrough pain episode that occurs within 48 hours after brachial plexus block.	Within 48 hours after block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Hospital of Shanxi Medical University

Investigators

Study Director: Li li Wang, Second Hospital of Shanxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2025

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

September 20, 2026

Study Registration Dates

First Submitted

September 12, 2026

First Submitted That Met QC Criteria

September 17, 2026

First Posted (Actual)

September 22, 2026

Study Record Updates

Last Update Posted (Actual)