tDCS for Reducing the Incidence of OEI After Cesarean Section

NCT07569783 | Not Yet Recruiting DMC

• 1 other identifier: 2026-K102-01
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Itching Symptoms; Itching Caused by Epidural Use of Opioids

Keywords

Transcranial direct current stimulation; Opioid-induced Pruritus after Epidural Administration; Cesarean section

Outcome Measures

Primary Outcomes (1)

• Incidence of itching within 24 hours after surgery (defined as VAS itching score ≥1)

  24 hours after surgery

Secondary Outcomes (4)

• 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

  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

  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)

  Within 72 hours after surgery

• Preoperative and postoperative 24h serum histamine, trypsin-like enzyme, TNF-α, IL-6, β-endorphin, and gastrin-releasing peptide precursor (ProGRP) levels

  24 hours before surgery and 24 hours after surgery

Study Arms (2)

control group (sham stimulation group)

SHAM COMPARATOR

Device: Transcranial direct current stimulation

Case group (tDCS group)

EXPERIMENTAL

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

Patients in the transcranial direct current stimulation (tDCS) group had the anode of the tDCS device placed over the left dorsolateral prefrontal cortex (F3 region) and the cathode over the right mastoid. tDCS was administered on the day of surgery (starting within 5 minutes after fetal delivery and terminating after the surgery upon transfer to the PACU). The current intensity was 1.5 mA. Patients in the sham stimulation group had the anode placed over the left dorsolateral prefrontal cortex (F3 region) and the cathode over the right mastoid, with a current of 1.5 mA applied only during the initial 30 seconds after stimulation begins, after which the current was reduced to 0 mA. All other procedures (electrode placement, stimulation duration, intervention frequency) were identical to the experimental group.

Case group (tDCS group); control group (sham stimulation group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ① 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.

You may not qualify if:

• ① 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);
• ⑤ Use of medications within the past week that may affect itch assessment, such as antihistamines, 5-HT3 receptor antagonists, or anti-inflammatory drugs.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

chao chao zhong, Doctor of Medicine

CONTACT

15152460489; zhong249767626@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Researcher

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share