Application of Cheek Acupuncture in Vaginal Tightening Surgery

Not Applicable

Not yet recruiting

• Conditions: Pain Vulva
• Interventions: Procedure: acupuncture treatment

• Registration Number: NCT06587711
• Lead Sponsor: The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-31
• Status Verified: 2024-09
• Study Start: 2024-09
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-09
• Last Update Submitted: 2024-09-11
• Last Update Posted: 2024-09-19
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cheek acupuncture treatmnet	acupuncture treatment	Patients in the experimental group are treated with cheek acupuncture.
sham acupuncture treatment	acupuncture treatment	Patients in the control group are treated with sham acupuncture.

Primary Outcome Measures

Name	Time	Method
Intraoperative opioid consumption	End of surgery	Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption

Secondary Outcome Measures

Name	Time	Method
Patient intravenous controlled analgesia (PCIA) pump consumption	24 hours after surgery	PCIA pump consumption in 24 hours after surgery
the rest numerical rating scale (NRS) scores	24 hours after surgery, 48 hours after surgery	0\~11，a higher score means a better outcome
the coughing numerical rating scale (NRS) scores	24 hours after surgery, 48 hours after surgery	0\~11，a higher score means a better outcome
15-item quality of recovery (QoR-15)	1 day after surgery, 2 day after surgery	0\~150, a higher score means a better outcome
Athens Insomnia Scale (AIS)	24 hours after surgery, 48 hours after surgery	0\~24, a lower score means a better outcome
Hospital Anxiety and Depression Scale（HADS）	24 hours after surgery, 48 hours after surgery	HADS(A) and HADS(D), 0\~21, respectively, a lower score means a better outcome
Patient satisfaction	48 hours after surgery	patient satisfaction on a Likert scale (1\~5,a higher score means a better satisfaction)
Systolic blood pressure (SBP)	Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery	Intraoperative hemodynamics
Diastolic blood pressure (DBP)	Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery	Intraoperative hemodynamics
Mean blood pressure (MBP)	Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery	Intraoperative hemodynamics
Heart rate (HR)	Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery	Intraoperative hemodynamics
Opioid-related side effects	0~48 hours after surgery	postoperative nausea and vomiting (PONV), dizziness, headache, pruritus, and respiratory depression
Acupuncture-related side effects	0~48 hours after surgery	hematoma，infection
Intraoperative dexmedetomidine consumption	End of surgery
Intraoperative midazolam consumption	End of surgery
Respiratory rates (RR)	Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
the partial pressure of end-tidal carbon dioxide (PetCO2)	Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery

Trial Locations

Locations (1)

Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China