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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cheek acupuncture treatmnet | Experimental | Patients in the experimental group are treated with cheek acupuncture. |
|
| sham acupuncture treatment | Sham Comparator | Patients in the control group are treated with sham acupuncture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative opioid consumption | Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption | End of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient intravenous controlled analgesia (PCIA) pump consumption | PCIA pump consumption in 24 hours after surgery | 24 hours after surgery |
| the rest numerical rating scale (NRS) scores | 0~11，a higher score means a better outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Chunmei, doctorate | Contact | +8618611612186 | chunmeichen2008@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yang Dong, doctorate | Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | 010 | China |
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| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 24 hours after surgery, 48 hours after surgery |
| the coughing numerical rating scale (NRS) scores | 0~11，a higher score means a better outcome | 24 hours after surgery, 48 hours after surgery |
| 15-item quality of recovery (QoR-15) | 0~150, a higher score means a better outcome | 1 day after surgery, 2 day after surgery |
| Athens Insomnia Scale (AIS) | 0~24, a lower score means a better outcome | 24 hours after surgery, 48 hours after surgery |
| Hospital Anxiety and Depression Scale（HADS） | HADS(A) and HADS(D), 0~21, respectively, a lower score means a better outcome | 24 hours after surgery, 48 hours after surgery |
| Patient satisfaction | patient satisfaction on a Likert scale (1~5,a higher score means a better satisfaction) | 48 hours after surgery |
| Systolic blood pressure (SBP) | Intraoperative hemodynamics | Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery |
| Diastolic blood pressure (DBP) | Intraoperative hemodynamics | Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery |
| Mean blood pressure (MBP) | Intraoperative hemodynamics | Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery |
| Heart rate (HR) | Intraoperative hemodynamics | Enter the operating room,15 minutes after anesthesia administration, surgery onset, 1 hour of surgery, end of surgery |
| Opioid-related side effects | postoperative nausea and vomiting (PONV), dizziness, headache, pruritus, and respiratory depression | 0~48 hours after surgery |
| Acupuncture-related side effects | hematoma，infection | 0~48 hours after surgery |
| 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 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |