Application of Cheek Acupuncture in Vaginal Tightening Surgery

NCT06587711 | Not Yet Recruiting

• 1 other identifier: PlasticSurgeryHPecking
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Vulva

Keywords

Acupuncture; Analgesia; Vaginal tighting surgery

Outcome Measures

Primary Outcomes (1)

• Intraoperative opioid consumption

  Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption

  End of surgery

Secondary Outcomes (17)

• Patient intravenous controlled analgesia (PCIA) pump consumption

  24 hours after surgery

• the rest numerical rating scale (NRS) scores

  24 hours after surgery, 48 hours after surgery

• the coughing numerical rating scale (NRS) scores

  24 hours after surgery, 48 hours after surgery

• 15-item quality of recovery (QoR-15)

  1 day after surgery, 2 day after surgery

• Athens Insomnia Scale (AIS)

  24 hours after surgery, 48 hours after surgery

Study Arms (2)

cheek acupuncture treatmnet

EXPERIMENTAL

Patients in the experimental group are treated with cheek acupuncture.

Procedure: acupuncture treatment

sham acupuncture treatment

SHAM COMPARATOR

Patients in the control group are treated with sham acupuncture.

Procedure: acupuncture treatment

Interventions

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.

cheek acupuncture treatmnet; sham acupuncture treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Beijing, Beijing Municipality, 010, China

Location

MeSH Terms

Conditions

Vulvodynia; Agnosia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yang Dong, doctorate

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

  STUDY CHAIR

Central Study Contacts

Chen Chunmei, doctorate

CONTACT

+8618611612186; chunmeichen2008@163.com

Study Design

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

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)