Effectiveness of Cheek Acupuncture Therapy for Pain Control After Cesarean Delivery

NCT ID: NCT06795594

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-05
• Study Completion Date: 2025-03-10

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.

Detailed Description

Pain control after cesarean delivery, if inadequately managed, can impact the prognosis of the mother and the health of the infant. There is an urgent need to explore safer, more effective, and straightforward non-pharmacological adjunctive interventions to alleviate the pain associated with cesarean section. Cheek acupuncture therapy is a green micro-acupuncture treatment that has shown significant improvement in various types of pain and holds great potential for relieving perioperative pain. To practice the concept of perioperative acupuncture medicine, this study aims to investigate whether cheek acupuncture therapy can alleviate postoperative pain in cesarean section patients and to explore the mechanisms by which it exerts its effects, through a prospective randomized controlled clinical trial.

Conditions

Acupuncture Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cheek Acupuncture group

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.

Group Type: EXPERIMENTAL

cheek acupuncture

Intervention Type: PROCEDURE

Cheek Acupuncture

sufentanil 2 µg/kg + ondansetron 0.2 mg/kg

Intervention Type: 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.

Control group

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.

Group Type: SHAM_COMPARATOR

sufentanil 2 µg/kg + ondansetron 0.2 mg/kg

Intervention Type: 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.

Interventions

cheek acupuncture

Cheek Acupuncture

Intervention Type: PROCEDURE

sufentanil 2 µg/kg + ondansetron 0.2 mg/kg

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients are classified as American Society of Anesthesiologists (ASA) physical status I to III.

2. Scheduled for elective cesarean delivery under spinal anesthesia.

3. Patients are aged between 19 to 45 years old.

4. Patients have provided written informed consent.

Exclusion Criteria

1. Local skin infection at the acupuncture sites in the cheek area.

2. Cases where spinal anesthesia fails and general anesthesia is required.

3. Patients with conditions such as recurrent alcohol abuse, fever, convulsions, or cardiopulmonary failure.

4. Patients who have used opioid medications at least 6 months prior to surgery.

5. Patients who are unable to understand the consent form and study questionnaire, including those with cognitive impairments.

6. Patients with a history of psychiatric illness.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guyan Wang

Role: STUDY_DIRECTOR

Beijing Tongren Hospital

Locations

Beijing Tongren Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

TREC2024-KY090.R1

Identifier Type: -

Identifier Source: org_study_id