Effectiveness of Cheek Acupuncture Therapy for Pain Control After Cesarean Delivery

Beijing Tongren Hospital80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acupuncture Analgesia

Interventions

cheek acupuncturePROCEDURE

Cheek Acupuncture

sufentanil 2 µg/kg + ondansetron 0.2 mg/kgDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

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.

Time frame: 24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment

Secondary Outcomes

the proportion of patients with NRS pain score ≥ 6

Assess the proportion of severe pain by calculating the ratio of NRS pain scores that are greater than or equal to 6.

Time frame: 24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment

NRS pain score during movement

Time frame: morning of the day of discharge (assessed up 7 days)

The Hospital Anxiety and Depression Scale (HADS)-A

The Hospital Anxiety and Depression Scale (HADS)-A is a subscale of the HADS, which is a self-assessment questionnaire used to screen for symptoms of anxiety and depression in patients within a non-psychiatric hospital setting. The 'A' stands for Anxiety, and the HADS-A specifically measures the severity of anxiety symptoms. It consists of 7 items rated on a 4-point scale, with scores ranging from 0 to 21, where higher scores indicate greater anxiety.

Time frame: morning of the day of discharge (assessed up 7 days)

HADS-D score

The Hospital Anxiety and Depression Scale (HADS)-D is a subscale of the HADS, which is designed to identify anxiety and depression in patients within hospital settings. The 'D' stands for Depression, and this subscale specifically assesses the severity of depressive symptoms. It includes 7 items rated on a 4-point scale, with scores ranging from 0 to 21, where higher scores indicate more severe depressive symptoms.

Data from ClinicalTrials.gov

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