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NCT Number: NCT07833930

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Hospital of Shanxi Medical University

Taiyuan, China

Location status: Recruiting

Location contact

Zheng Guo

CONTACT

[email protected]

+863513365790

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wen bo Wang

CONTACT

[email protected]

+8618636532676

Sponsors and collaborators

Lead sponsor

Second Hospital of Shanxi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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