- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07569783
tDCS for Reducing the Incidence of OEI After Cesarean Section
30 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
104
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: chao chao zhong, Doctor of Medicine
- Numero di telefono: 15152460489
- Email: zhong249767626@163.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore fittizio: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of itching within 24 hours after surgery (defined as VAS itching score ≥1)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Within 72 hours after surgery
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Within 72 hours after surgery
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Preoperative and postoperative 24h serum histaminelevels
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 giugno 2026
Completamento primario (Stimato)
31 dicembre 2026
Completamento dello studio (Stimato)
20 febbraio 2027
Date di iscrizione allo studio
Primo inviato
23 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 aprile 2026
Primo Inserito (Effettivo)
6 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 giugno 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-K102-01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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