Postoperative PainNCT07833930
Incidence and Clinical Features of Breakthrough Pain After Brachial Plexus Block in Diabetic Patients
An observational study of Postoperative Pain, run by Second Hospital of Shanxi Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2025to 20 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Hospital of Shanxi Medical University
Taiyuan
Zheng Guo, +863513365790, guozheng713@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Keywords
- Brachial plexus block, Rebound pain, Type 2 diabetes mellitus
- Medical subject headings
- Pain, Postoperative, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 48 hours after brachial plexus block
Secondary outcomes (4)
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.
Measured: Within 48 hours after block
Onset time of first rebound-breakthrough pain
Time interval from completion of brachial plexus block to the first occurrence of rebound-breakthrough pain.
Measured: Within 48 hours after block
Frequency of rebound-breakthrough pain episodes
Total number of rebound-breakthrough pain episodes within 48 hours after brachial plexus block.
Measured: Within 48 hours after block
Duration of each rebound-breakthrough pain episode
Duration of each rebound-breakthrough pain episode that occurs within 48 hours after brachial plexus block.
Measured: Within 48 hours after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start20 Sep 2025
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
- Investigators
- Li li Wang, Study director, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833930
- Sponsor's protocol ID
- [2025]YX277
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on Incidence and Clinical Characteristics of Breakthrough Pain Following Brachial Plexus Block in Adult Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07833930
- Acronym / sponsor ID
- [2025]YX277
- Conditions
- Postoperative Pain
- Keywords
- Brachial plexus block, Rebound pain, Type 2 diabetes mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Within 48 hours after brachial plexus block
Time frame: Within 48 hours after block
Onset time of first rebound-breakthrough pain
Time frame: Within 48 hours after block
Frequency of rebound-breakthrough pain episodes
Time frame: Within 48 hours after block
Duration of each rebound-breakthrough pain episode
Time frame: Within 48 hours after block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li li Wang study director
Second Hospital of Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Second Hospital of Shanxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen bo Wang (+8618636532676, 1525565253@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative rebound-breakthrough pain (time frame: Within 48 hours after brachial plexus block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.