Acupuncture Analgesia
Conditions
Keywords
Cheek acupuncture therapy, Acupuncture, Cesarean delivery, Pain control, Postoperative pain management
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.
Interventions
PROCEDUREcheek acupuncture
Cheek Acupuncture
DRUGsufentanil 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.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (0-10) pain score during movement | 24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS pain score during movement | morning of the day of discharge (assessed up 7 days) | 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. |
| The Hospital Anxiety and Depression Scale (HADS)-A | morning of the day of discharge (assessed up 7 days) | 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. |
| HADS-D score | morning of the day of discharge (assessed up 7 days) | 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. |
| ISI score | morning of the day of discharge (assessed up 7 days) | The ISI-(0-28) refers to the Insomnia Severity Index, which is a self-administered questionnaire used to evaluate the severity of insomnia. It consists of 7 items scored on a 5-point Likert scale, ranging from 0 (no difficulty) to 4 (extreme difficulty). The total score ranges from 0 to 28, with higher scores indicating greater severity of insomnia. |
| 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 | Assess the proportion of severe pain by calculating the ratio of NRS pain scores that are greater than or equal to 6. |
| HCRP | 48 hours postoperatively | HCRP stands for High-Sensitivity C-Reactive Protein. It is a blood test that measures the levels of C-reactive protein (CRP), which is a marker of inflammation in the body. High-sensitivity CRP tests can detect low levels of CRP, making it a useful tool for monitoring inflammation, cardiovascular risk, and the effectiveness of treatments for various inflammatory conditions. |
| Beta-endorphin | 48 hours postoperatively | Beta-endorphin is an endogenous opioid peptide produced by the body, consisting of 31 amino acids. It is a natural painkiller and plays a role in reducing pain and stress. Beta-endorphin is released in response to stress, pain, or the use of opioids, and it contributes to the body's reward system and regulation of mood. It is also associated with the release of adrenaline during stress or intense physical activity. |
| Postoperative adverse reactions | From date of randomization until the date of discharge, assessed up to 7 days | Explore whether cheek acupuncture intervention increases postoperative adverse reactions, including dizziness, abdominal bloating, nausea, vomiting, fatigue and so on. |
| Postoperative severe complications | From date of randomization until the date of discharge, assessed up to 7 days | Postoperative severe complications, including pulmonary complications, heart failure, liver dysfunction, kidney dysfunction, coagulation function, SIRS (Systemic Inflammatory Response Syndrome), stroke, and so on. |
| QoR15 score | morning of the day of discharge (assessed up 7 days) | The QoR15 score is a measure used to assess the quality of recovery following surgery. It stands for Quality of Recovery-15, and it is a 15-item questionnaire that evaluates various aspects of a patient's recovery, such as pain, nausea, vomiting, fatigue, and return to physical and cognitive function. The score ranges from 0 to 150, with a higher score indicating a better quality of recovery. |
Countries
China
Outcome results
None listed