Effectiveness of Cheek Acupuncture Therapy for Pain Control After Cesarean Delivery

NCT06795594 | Completed DMC

• 1 other identifier: TREC2024-KY090.R1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acupuncture Analgesia

Keywords

Cheek acupuncture therapy; Acupuncture; Cesarean delivery; Pain control; Postoperative pain management

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• 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)

Study Arms (2)

Cheek Acupuncture group

EXPERIMENTAL

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.

Procedure: cheek acupuncture; Drug: sufentanil 2 µg/kg + ondansetron 0.2 mg/kg

Control group

SHAM COMPARATOR

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.

Drug: sufentanil 2 µg/kg + ondansetron 0.2 mg/kg

Interventions

cheek acupuncture PROCEDURE

Cheek Acupuncture

Cheek Acupuncture group

sufentanil 2 µg/kg + ondansetron 0.2 mg/kg DRUG

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.

Cheek Acupuncture group; Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients are classified as American Society of Anesthesiologists (ASA) physical status I to III.
• Scheduled for elective cesarean delivery under spinal anesthesia.
• Patients are aged between 19 to 45 years old.
• Patients have provided written informed consent.

You may not qualify if:

• Local skin infection at the acupuncture sites in the cheek area.
• Cases where spinal anesthesia fails and general anesthesia is required.
• Patients with conditions such as recurrent alcohol abuse, fever, convulsions, or cardiopulmonary failure.
• Patients who have used opioid medications at least 6 months prior to surgery.
• Patients who are unable to understand the consent form and study questionnaire, including those with cognitive impairments.
• Patients with a history of psychiatric illness.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, 100730, China

Location

MeSH Terms

Conditions

Agnosia

Interventions

Sufentanil; Ondansetron

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Guyan Wang

  Beijing Tongren Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: January 28, 2025
• Study Start: January 5, 2025
• Primary Completion: March 10, 2025
• Study Completion: March 10, 2025
• Last Updated: March 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)