- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07569783
tDCS for Reducing the Incidence of OEI After Cesarean Section
16 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
104
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Chao Chao Zhong, M.D.
- Número de telefone: 15152460489
- E-mail: zhong249767626@163.com
Locais de estudo
-
-
Jiangsu
-
Nantong, Jiangsu, China, 226001
- Recrutamento
- Affiliated Hospital of Nantong University
-
Contato:
- Chao-Chao Zhong, M.D.;P.H.D
- Número de telefone: 15152460489
- E-mail: zhong249767626@163.com
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Falso: control group (sham stimulation group)
|
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.
|
|
Experimental: Case group (tDCS group)
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of itching within 24 hours after surgery (defined as VAS itching score ≥1)
Prazo: 24 hours after surgery
|
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.
|
24 hours after surgery
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
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
Prazo: 12 hours post-operation and 48 hours post-operation
|
12 hours post-operation and 48 hours post-operation
|
|
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
Prazo: 12 hours, 24 hours, and 48 hours after surgery
|
12 hours, 24 hours, and 48 hours after surgery
|
|
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)
Prazo: Within 72 hours after surgery
|
Within 72 hours after surgery
|
|
Preoperative and postoperative 24h serum histaminelevels
Prazo: 24 hours before surgery and 24 hours after surgery
|
24 hours before surgery and 24 hours after surgery
|
|
Preoperative and postoperative 24h trypsin-like enzymelevels
Prazo: 24 hours before surgery and 24 hours after surgery
|
24 hours before surgery and 24 hours after surgery
|
|
Preoperative and postoperative 24h TNF-α levels
Prazo: 24 hours before surgery and 24 hours after surgery
|
24 hours before surgery and 24 hours after surgery
|
|
Preoperative and postoperative 24h IL-6 levels
Prazo: 24 hours before surgery and 24 hours after surgery
|
24 hours before surgery and 24 hours after surgery
|
|
Preoperative and postoperative 24h β-endorphin levels
Prazo: 24 hours before surgery and 24 hours after surgery
|
24 hours before surgery and 24 hours after surgery
|
|
Preoperative and postoperative 24h gastrin-releasing peptide precursor (ProGRP) levels
Prazo: 24 hours before surgery and 24 hours after surgery
|
24 hours before surgery and 24 hours after surgery
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
10 de maio de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2026
Conclusão do estudo (Estimado)
20 de fevereiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
23 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de abril de 2026
Primeira postagem (Real)
6 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-K102-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .