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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSecond Hospital of Shanxi Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

216 Participants
are grouped into 2 trial groups
Group A: Patients with type 2 diabetes mellitus
Group B: Patients without diabetes mellitus

Trial outcomes

Primary outcomes

1

Incidence of postoperative rebound-breakthrough pain

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.

Time frame
Within 48 hours after brachial plexus block

Secondary outcomes

1

Within 48 hours after brachial plexus block

Peak numerical rating scale (NRS, 0-10) score during each rebound-breakthrough pain episode. Higher score indicates more severe pain.

Time frame
Within 48 hours after block
2

Onset time of first rebound-breakthrough pain

Time interval from completion of brachial plexus block to the first occurrence of rebound-breakthrough pain.

Time frame
Within 48 hours after block
3

Frequency of rebound-breakthrough pain episodes

Total number of rebound-breakthrough pain episodes within 48 hours after brachial plexus block.

Time frame
Within 48 hours after block
4

Duration of each rebound-breakthrough pain episode

Duration of each rebound-breakthrough pain episode that occurs within 48 hours after brachial plexus block.

Time frame
Within 48 hours after block

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.