tDCS for Reducing the Incidence of OEI After Cesarean Section
30 juni 2026 bijgewerkt door: Chaochao Zhong, Affiliated Hospital of Nantong University
Study on the Preventive and Therapeutic Effects and Mechanism of Transcranial Direct Current Stimulation on Morphine-Induced Itching After Cesarean Section: A Randomized Clinical Controlled Trial
Cesarean section is the most common obstetric surgery worldwide.
Epidural anesthesia has become the preferred anesthesia method for cesarean sections due to its definite analgesic effect and minimal impact on mother and baby.
To ensure postoperative analgesia, intrathecal administration of morphine (the preferred opioid for obstetric intrathecal analgesia) is a routine clinical protocol, but morphine-induced postoperative pruritus is a common adverse reaction.
A study targeting the cesarean section population confirmed that the incidence of pruritus after epidural morphine administration is as high as 40%-75%.Transcranial direct current stimulation (tDCS) can enhance the activity of GABAergic inhibitory interneurons in the spinal dorsal horn through the cortical-spinal descending pathway, reverse the inhibitory effect of morphine on them, and restore negative feedback regulation of itch-specific GRPR⁺ neurons; at the same time, it downregulates the phosphorylation level and membrane expression of μ-opioid receptors in the spinal dorsal horn, weakening the receptor activation efficiency of morphine.
On the other hand, tDCS can reduce peripheral nerve excitability, decrease mast cell degranulation in the skin, and reduce the release of histamine and tryptase; simultaneously, it inhibits the activation of glial cells in the spinal cord/cortex, decreases the secretion of pro-inflammatory factors such as TNF-α and IL-6, and blocks the vicious cycle of 'inflammation-receptor upregulation-itch exacerbation,' thereby reducing the occurrence of itch.This study aims to explore the effect of transcranial direct current stimulation (tDCS) on the incidence of morphine-induced itching after cesarean section by inhibiting the central itch perception circuits in cesarean section patients and antagonizing the disinhibitory effects mediated by μ-opioid receptors in the spinal dorsal horn.
Studie Overzicht
Toestand
Nog niet aan het werven
Studietype
Ingrijpend
Inschrijving (Geschat)
104
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: chao chao zhong, Doctor of Medicine
- Telefoonnummer: 15152460489
- E-mail: zhong249767626@163.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Age 18-40 years, gestational age 37-41 weeks, singleton full-term pregnancy;
- Planned elective or emergency cesarean section, using epidural anesthesia (0.1~0.2 mg/kg of morphine administered intrathecally during surgery);
- American Society of Anesthesiologists (ASA) classification I-III;
- Conscious and able to cooperate to complete scale assessments, serum sample collection, and postoperative follow-up;
- Voluntarily participate in the study and sign the informed consent form.
Exclusion Criteria:
- Presence of contraindications for tDCS (such as skull defects, intracranial metal implants, history of epilepsy, coagulation disorders);
- Allergy to opioids or a history of severe OEI;
- Presence of skin diseases (such as eczema, urticaria), liver diseases (cholestasis), mental disorders, or cognitive impairments;
- Coexisting pregnancy complications (preeclampsia, gestational diabetes, autoimmune diseases);
- Use of medications within the past week that may affect itch assessment, such as antihistamines, 5-HT3 receptor antagonists, or anti-inflammatory drugs.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Sham-vergelijker: control group (sham stimulation group)
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Sham stimulation group (control group): The anode of the electrical stimulator is placed on the left dorsolateral prefrontal cortex (F3 region) and the cathode on the right mastoid area.
A current of 1.5 mA is applied only during the first 30 seconds after the start of stimulation, after which the current is reduced to 0 mA.
All other procedures (electrode placement, stimulation duration, intervention frequency) are the same as those in the experimental group.
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Experimenteel: Case group (tDCS group)
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Patients in the transcranial direct current stimulation (tDCS) group had the anode of the tDCS device placed on the left dorsolateral prefrontal cortex (F3 area) and the cathode on the right mastoid.
The tDCS was administered on the day of surgery (starting within 5 minutes after delivery of the fetus and ending upon transfer to the PACU after surgery).
The current intensity was 1.5 mA.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of itching within 24 hours after surgery (defined as VAS itching score ≥1)
Tijdsspanne: 24 hours after surgery
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The VAS scoring standard for the degree of itching is a tool used to assess the severity of itching.
VAS stands for Visual Analog Scale.
The following are the standards for VAS scoring of itching severity: 0 points: No itching.
1-3 points: Mild itching, does not affect daily life.
4-6 points: Moderate itching, somewhat affects daily life.
7-9 points: Severe itching, seriously affects daily life, requires active treatment.
10 points: Extremely severe itching, unbearable, requires immediate treatment.
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24 hours after surgery
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Incidence of itching at 12 and 48 hours postoperatively; VAS scores for itching at each time point; duration of itching and time of peak appearance
Tijdsspanne: 12 hours post-operation and 48 hours post-operation
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12 hours post-operation and 48 hours post-operation
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Number of times the analgesic pump was pressed and the doses of additional morphine within 48 hours postoperatively; VAS pain scores at 12, 24, and 48 hours postoperatively
Tijdsspanne: 12 hours, 24 hours, and 48 hours after surgery
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12 hours, 24 hours, and 48 hours after surgery
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Maternal adverse reactions (nausea and vomiting, drowsiness, dizziness, ear pain, skin erythema) incidence; neonatal 1-minute and 5-minute Apgar scores, birth weight, complications within 72 hours (jaundice, shortness of breath, feeding difficulties)
Tijdsspanne: Within 72 hours after surgery
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Within 72 hours after surgery
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Preoperative and postoperative 24h serum histaminelevels
Tijdsspanne: 24 hours before surgery and 24 hours after surgery
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24 hours before surgery and 24 hours after surgery
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Preoperative and postoperative 24h trypsin-like enzymelevels
Tijdsspanne: 24 hours before surgery and 24 hours after surgery
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24 hours before surgery and 24 hours after surgery
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Preoperative and postoperative 24h TNF-α levels
Tijdsspanne: 24 hours before surgery and 24 hours after surgery
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24 hours before surgery and 24 hours after surgery
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Preoperative and postoperative 24h IL-6 levels
Tijdsspanne: 24 hours before surgery and 24 hours after surgery
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24 hours before surgery and 24 hours after surgery
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Preoperative and postoperative 24h β-endorphin levels
Tijdsspanne: 24 hours before surgery and 24 hours after surgery
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24 hours before surgery and 24 hours after surgery
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Preoperative and postoperative 24h gastrin-releasing peptide precursor (ProGRP) levels
Tijdsspanne: 24 hours before surgery and 24 hours after surgery
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24 hours before surgery and 24 hours after surgery
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
15 juni 2026
Primaire voltooiing (Geschat)
31 december 2026
Studie voltooiing (Geschat)
20 februari 2027
Studieregistratiedata
Eerst ingediend
23 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
29 april 2026
Eerst geplaatst (Werkelijk)
6 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
30 juni 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2026-K102-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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