Clinical trial NCT06587711: Application of Cheek Acupuncture in Vaginal Tightening Surgery
Official title: Application of Cheek Acupuncture in Vaginal Tightening Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Vulva
Keywords: Acupuncture
Analgesia
Vaginal tighting surgery
Lead sponsor: The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intraoperative opioid consumption
timeFrame: End of surgery
Secondary outcomes:
measure: Patient intravenous controlled analgesia (PCIA) pump consumption
timeFrame: 24 hours after surgery
measure: the rest numerical rating scale (NRS) scores
timeFrame: 24 hours after surgery, 48 hours after surgery
measure: the coughing numerical rating scale (NRS) scores
timeFrame: 24 hours after surgery, 48 hours after surgery
measure: 15-item quality of recovery (QoR-15)
timeFrame: 1 day after surgery, 2 day after surgery
measure: Athens Insomnia Scale (AIS)
timeFrame: 24 hours after surgery, 48 hours after surgery
measure: Hospital Anxiety and Depression Scale（HADS）
timeFrame: 24 hours after surgery, 48 hours after surgery
measure: Patient satisfaction
timeFrame: 48 hours after surgery
measure: Systolic blood pressure (SBP)
timeFrame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
measure: Diastolic blood pressure (DBP)
timeFrame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
measure: Mean blood pressure (MBP)
timeFrame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
measure: Heart rate (HR)
timeFrame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
measure: Opioid-related side effects
timeFrame: 0~48 hours after surgery
measure: Acupuncture-related side effects
timeFrame: 0~48 hours after surgery
measure: Intraoperative dexmedetomidine consumption
timeFrame: End of surgery
measure: Intraoperative midazolam consumption
timeFrame: End of surgery
measure: Respiratory rates (RR)
timeFrame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
measure: the partial pressure of end-tidal carbon dioxide (PetCO2)
timeFrame: Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Yang Dong, doctorate
role: STUDY_CHAIR
References: