Application of Cheek Acupuncture in Vaginal Tightening Surgery

ConditionPain Vulva
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorThe Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • acupuncture treatment

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: cheek acupuncture treatmnetExperimental treatment 1 intervention
Group B: sham acupuncture treatmentSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative opioid consumption

Intraoperative remifentanil dosage Intraoperative remifentanil dosage Intraoperative remifentanil consumption

Time frame
End of surgery

Secondary outcomes

1

Patient intravenous controlled analgesia (PCIA) pump consumption

PCIA pump consumption in 24 hours after surgery

Time frame
24 hours after surgery
2

the rest numerical rating scale (NRS) scores

0\~11,a higher score means a better outcome

Time frame
24 hours after surgery, 48 hours after surgery
3

the coughing numerical rating scale (NRS) scores

0\~11,a higher score means a better outcome

Time frame
24 hours after surgery, 48 hours after surgery
4

15-item quality of recovery (QoR-15)

0\~150, a higher score means a better outcome

Time frame
1 day after surgery, 2 day after surgery

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: