Effectiveness of Cheek Acupuncture Therapy for Pain Control After Cesarean Delivery
Cheek Acupuncture Therapy Vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
Cheek Acupuncture Therapy Vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
Sponsor study identifier
interventional
80
1 country
1
Study Start
January 5, 2025
Actual (reported)Primary Completion
March 10, 2025
Actual (reported)Study Completion
March 10, 2025
Actual (reported)This study investigates whether cheek acupuncture therapy can alleviate postoperative pain in cesarean section patients and explores its mechanisms of action through a prospective randomized controlled clinical trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 10, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 8, 2024
Actual (reported)January 5, 2025
Actual (reported)January 28, 2025
Actual (reported)March 10, 2025
Actual (reported)March 10, 2025
Actual (reported)Numeric Rating Scale (0-10) pain score during movement
Numeric Rating Scale, this scale is a validated tool for measuring pain intensity, with scores ranging from 0 (no pain) to 10 (the most severe pain imaginable).The higher the score, the more severe the pain.
24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment
the proportion of patients with NRS pain score ≥ 6
24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment
NRS pain score during movement
morning of the day of discharge (assessed up 7 days)
The Hospital Anxiety and Depression Scale (HADS)-A
morning of the day of discharge (assessed up 7 days)
HADS-D score
morning of the day of discharge (assessed up 7 days)
ISI score
morning of the day of discharge (assessed up 7 days)
Each patient in the cheek acupuncture group received cheek acupuncture therapy as a supplement to the postoperative patient-controlled analgesia pump. The selected cheek acupuncture points included four bilateral points for the neck, back, waist, and sacrum, as well as four abdominal holographic points, totaling eight points. Cheek acupuncture procedure: The patient was placed in a supine position, and the acupoint skin was routinely disinfected. Acupuncture needles of 0.15mm by 15mm were used, inserted quickly and vertically to a depth of 10 to 15mm without seeking the sensation of "qi" arrival. The needles were left in place for 30 minutes and then removed, followed by applying a cotton ball to press on the needle holes for a moment. The intervention was conducted twice, each time for 30 minutes, with the first session immediately after completing the anesthesia operation and the second session at 23.5 hours postoperatively.
The control group used only a patient-controlled analgesia (PCA) pump for postoperative pain relief. The pump contained 2 micrograms per kilogram of sufentanil and 0.2 milligrams per kilogram of ondansetron, with a total volume of 100 milliliters. The pump was set to deliver a continuous infusion of 2 milliliters per hour, with the option for patients to self-administer an additional 2-milliliter bolus dose as needed, with a minimum interval of 15 minutes between doses. If the primary analgesic measures were insufficient to control pain, diclofenac sodium suppositories were provided as rescue analgesia, based on patient needs. The use of these suppositories was based on individual patient pain assessments and the need for additional pain relief.
The patient-controlled analgesia (PCA) pump held a solution of 2 µg/kg sufentanil and 0.2 mg/kg ondansetron in 100 ml. It infused 2 ml/hour continuously, allowing patients to self-administer an extra 2 ml bolus every 15 minutes if needed. For inadequate pain control, diclofenac sodium suppositories were used as rescue analgesia, depending on individual pain assessments and the requirement for extra relief.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
sufentanil 2 µg/kg + ondansetron 0.2 mg/kg
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordBeijing Tongren Hospital, Capital Medical University
Beijing, 100730, China
Guyan Wang
Beijing Tongren Hospital
80 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2024
First Posted
January 28, 2025
Study Start
January 5, 2025
Actual (reported)Linked from the registry description. Each source intervention is retained as reported.
In: sufentanil 2 µg/kg + ondansetron 0.2 mg/kg
In: sufentanil 2 µg/kg + ondansetron 0.2 mg/kg
Contact the study team to confirm eligibility.
Primary Completion
March 10, 2025
Actual (reported)Study Completion
March 10, 2025
Actual (reported)Last Updated
March 25, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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