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A study on the superiority of the new non-pharmacological passive electrical signal analgesic technology combined with non-steroidal anti-inflammatory drugs(NSAIDs) in alleviating severe pain at the cesarean section incision site, and the safety profile in humans.

A study on the superiority of the new non-pharmacological passive electrical signal analgesic technology combined with non-steroidal anti-inflammatory drugs(NSAIDs) in alleviating severe pain at the cesarean section incision site, and the safety profile in humans.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123790
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-05-06
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

A group:novel non-pharmacological, passive electrical signal analgesic device
B group:oral or intravenous non-steroidal anti-inflammatory drugsdevice

Sponsors

Peking Union Medical College, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1 .Patients undergoing cesarean section at term with singleton pregnancy; 2.Age between 18 and 45 years; 3. American Society of Anesthesiologists (ASA) physical status classification I–II; 4.No history of alcohol or anesthetic drug addiction; 5.No prenatal depression or other psychiatric disorders, and able to cooperate with all study procedures; 6.Good compliance, available for postpartum follow-up; 7.Complete clinical records and provision of informed consent.

Exclusion criteria

Exclusion criteria: 1.Patients with major organ dysfunction, such as severe cardiovascular, cerebrovascular, hepatic, or renal diseases; 2. Patients with pregnancy complicated by autoimmune diseases, preeclampsia, or gestational diabetes; 3. Patients who have taken opioid analgesics or anti-inflammatory drugs within 2 days prior to surgery; 4.Patients with a history of chronic pain; 5. Patients contraindicated for neuraxial anesthesia;6. Patients allergic to the study medication (Voltaren).

Design outcomes

Primary

MeasureTime frame
Sum of Pain Intensity Difference over 48 hours;

Secondary

MeasureTime frame
Safety (incidence of adverse reactions and complications);Scar severity ;Inflammatory cytokine levels ;Wound healing quality ;

Countries

China

Contacts

Public ContactZhou Qian

Peking Union Medical College, Chinese Academy of Medical Sciences

zqzht.student@sina.com+86 138 1186 5560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026