Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06587711

Application of Cheek Acupuncture in Vaginal Tightening Surgery

A large number of studies have shown that acupuncture can reduce perioperative pain in patients. Cheek acupuncture therapy is a new acupuncture treatment, which belongs to the microneedle system, that is, acupuncture at specific acupoint on the face, which can relieve patients' pain. In this study, the efficacy and safety of cheek acupuncture in patients undergoing vaginal tightening surgery was verified by observing the consumption of opioid, intraoperative hemodynamics, dosage of oral remedial analgesics, postoperative quality of recovery, patient satisfaction, incidence of side effects, etc.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pain Vulva Agnosia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urogenital Diseases Vulvar Diseases Vulvodynia

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 010, China

Location contact

Deng Xiaoming, master

CONTACT

[email protected]

+8618618158087

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-60 years, undergoing vaginal tightening surgery
  • American Society of Anesthesiologists (ASA) physical status I to II
  • Voluntary participation and signed an informed consent form

Exclusion criteria

  • Acute and/or chronic pain before surgery
  • History of congenital heart disease, arrhythmia, or hypertension
  • History of severe mental or neurological diseases, drug or psychotropic drug abuse
  • Cognitive dysfunction or inability to communicate.
  • The acupuncture acupoints are infected
  • Coagulation disorders
  • Patients with mandibular or zygomatic bone osteotomy

Treatment and study plan

Acupuncture Treatment

Procedure

Patients in experimental group received acupuncture at specific acupoint on the face, patients in control group received sham acupuncture at non-acupoint on the face.

Primary outcomes

  1. Intraoperative opioid consumption

    Time frame: End of surgery

    Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption

Secondary outcomes

  1. Patient intravenous controlled analgesia (PCIA) pump consumption

    Time frame: 24 hours after surgery

    PCIA pump consumption in 24 hours after surgery

  2. the rest numerical rating scale (NRS) scores

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

    0~11，a higher score means a better outcome

  3. the coughing numerical rating scale (NRS) scores

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

    0~11，a higher score means a better outcome

  4. 15-item quality of recovery (QoR-15)

    Time frame: 1 day after surgery, 2 day after surgery

    0~150, a higher score means a better outcome

  5. Athens Insomnia Scale (AIS)

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

    0~24, a lower score means a better outcome

  6. Hospital Anxiety and Depression Scale（HADS）

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

    HADS(A) and HADS(D), 0~21, respectively, a lower score means a better outcome

  7. Patient satisfaction

    Time frame: 48 hours after surgery

    patient satisfaction on a Likert scale (1~5,a higher score means a better satisfaction)

  8. Systolic blood pressure (SBP)

    Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery

    Intraoperative hemodynamics

  9. Diastolic blood pressure (DBP)

    Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery

    Intraoperative hemodynamics

  10. Mean blood pressure (MBP)

    Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery

    Intraoperative hemodynamics

  11. Heart rate (HR)

    Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery

    Intraoperative hemodynamics

  12. Opioid-related side effects

    Time frame: 0~48 hours after surgery

    postoperative nausea and vomiting (PONV), dizziness, headache, pruritus, and respiratory depression

  13. Acupuncture-related side effects

    Time frame: 0~48 hours after surgery

    hematoma，infection

  14. Intraoperative dexmedetomidine consumption

    Time frame: End of surgery

  15. Intraoperative midazolam consumption

    Time frame: End of surgery

  16. Respiratory rates (RR)

    Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery

  17. the partial pressure of end-tidal carbon dioxide (PetCO2)

    Time frame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Chunmei, doctorate

CONTACT

[email protected]

+8618611612186

Sponsors and collaborators

Lead sponsor

The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.