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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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Wen bo Wang
- Telefoonnummer: +8618636532676
- E-mail: 1525565253@qq.com
Studie Locaties
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Taiyuan, China
- Werving
- Second Hospital of Shanxi Medical University
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Contact:
- Zheng Guo
- Telefoonnummer: +863513365790
- E-mail: guozheng713@yahoo.com
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: CROSS_SECTIONAL
Cohorten en interventies
Groep / 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of postoperative rebound-breakthrough pain
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Within 48 hours after brachial plexus block
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Within 48 hours after block
|
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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Li li Wang, Second Hospital of Shanxi Medical University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Endocriene systeemziekten
- Postoperatieve complicaties
- Pathologische processen
- Metabole ziekten
- Glucosemetabolismestoornissen
- Suikerziekte
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Tekenen en symptomen
- Pijn, postoperatief
- Diabetes mellitus, type 2
Andere studie-ID-nummers
- [2025]YX277
Plan Individuele Deelnemersgegevens (IPD)
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