Pain Vulva
Conditions
Keywords
Acupuncture, Analgesia, Vaginal tighting surgery
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.
Interventions
PROCEDUREacupuncture treatment
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.
Sponsors
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative opioid consumption | End of surgery | Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Patient intravenous controlled analgesia (PCIA) pump consumption | 24 hours after surgery | PCIA pump consumption in 24 hours after surgery |
| 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 | — |
| Mean blood pressure (MBP) | Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery | Intraoperative hemodynamics |
Countries
China
Contacts
Primary ContactChen Chunmei, doctorate
Outcome results
None listed