Itching SymptomsNCT07569783
tDCS for Reducing the Incidence of OEI After Cesarean Section
A study testing Transcranial direct current stimulation in people with Itching Symptoms and Itching Caused by Epidural Use of Opioids, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Itching Symptoms, Itching Caused by Epidural Use of Opioids
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2026to 20 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated hospital of Nantong University
Nantong, Jiangsu, 226001
Chao-Chao Zhong, M.D.;P.H.D, 15152460489, zhong249767626@163.com
About this study
Official title: 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.
- Being tested
- Transcranial direct current stimulation, Transcranial direct current stimulation (placebo stimulation)
- Keywords
- Transcranial direct current stimulation, Opioid-induced Pruritus after Epidural Administration, Cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
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.
Transcranial direct current stimulation (placebo stimulation)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| control group (sham stimulation group) | Sham comparator | Not described Receives: Device: Transcranial direct current stimulation (placebo stimulation) |
| Case group (tDCS group) | Experimental | Not described Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery
Secondary outcomes (9)
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
Measured: 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
Measured: 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)
Measured: Within 72 hours after surgery
Preoperative and postoperative 24h serum histaminelevels
Measured: 24 hours before surgery and 24 hours after surgery
Preoperative and postoperative 24h trypsin-like enzymelevels
Measured: 24 hours before surgery and 24 hours after surgery
Preoperative and postoperative 24h TNF-α levels
Measured: 24 hours before surgery and 24 hours after surgery
Preoperative and postoperative 24h IL-6 levels
Measured: 24 hours before surgery and 24 hours after surgery
Preoperative and postoperative 24h β-endorphin levels
Measured: 24 hours before surgery and 24 hours after surgery
Preoperative and postoperative 24h gastrin-releasing peptide precursor (ProGRP) levels
Measured: 24 hours before surgery and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start10 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Itching SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaochao Zhong, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07569783
- Sponsor's protocol ID
- 2026-K102-01
- Status last verified
- Sep 2026
- First submitted
- 23 Apr 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No