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RecruitingNCT07569783Updated Sep 17, 2026

tDCS for Reducing the Incidence of OEI After Cesarean Section

An interventional study of Transcranial direct current stimulation and Transcranial direct current stimulation (placebo stimulation) in Itching Symptoms and Itching Caused by Epidural Use of Opioids, sponsored by Affiliated Hospital of Nantong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Affiliated Hospital of Nantong University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Itching Symptoms
  • Itching Caused by Epidural Use of Opioids

Keywords

  • Transcranial direct current stimulation
  • Opioid-induced Pruritus after Epidural Administration
  • Cesarean section
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
104 participants (estimated)

Study arms

  • Sham comparator
    control group (sham stimulation group)

    Device: Transcranial direct current stimulation (placebo stimulation)

  • Experimental
    Case group (tDCS group)

    Device: Transcranial direct current stimulation

Interventions

  • DeviceTranscranial direct current stimulation

    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.

  • DeviceTranscranial direct current stimulation (placebo stimulation)

    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.

05

What researchers measure

Primary outcomes

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

    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.

    Time frame: 24 hours after surgery

Secondary outcomes

  1. 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

    Time frame: 12 hours post-operation and 48 hours post-operation

  2. 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

    Time frame: 12 hours, 24 hours, and 48 hours after surgery

  3. 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)

    Time frame: Within 72 hours after surgery

  4. Preoperative and postoperative 24h serum histaminelevels

    Time frame: 24 hours before surgery and 24 hours after surgery

  5. Preoperative and postoperative 24h trypsin-like enzymelevels

    Time frame: 24 hours before surgery and 24 hours after surgery

  6. Preoperative and postoperative 24h TNF-α levels

    Time frame: 24 hours before surgery and 24 hours after surgery

  7. Preoperative and postoperative 24h IL-6 levels

    Time frame: 24 hours before surgery and 24 hours after surgery

  8. Preoperative and postoperative 24h β-endorphin levels

    Time frame: 24 hours before surgery and 24 hours after surgery

  9. Preoperative and postoperative 24h gastrin-releasing peptide precursor (ProGRP) levels

    Time frame: 24 hours before surgery and 24 hours after surgery

06

Study locations

1 of 1 sites recruiting
  • Affiliated hospital of Nantong University
    Nantong, Jiangsu 226001, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07569783
Lead sponsor
Affiliated Hospital of Nantong University
Responsible party
Chaochao Zhong (Chief Researcher, Affiliated Hospital of Nantong University) — Principal investigator
First posted
May 6, 2026
Start date
May 10, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Feb 20, 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Chao Chao Zhong, M.D.
Contact
zhong249767626@163.com
15152460489

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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