Cheek Acupuncture Therapy Vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Numeric Rating Scale (0-10) pain score during movement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: cheek acupuncture (Procedure)
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.
Intervention: sufentanil 2 µg/kg + ondansetron 0.2 mg/kg (Drug)
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.
Intervention: sufentanil 2 µg/kg + ondansetron 0.2 mg/kg (Drug)
Outcomes
Primary Outcomes
Numeric Rating Scale (0-10) pain score during movement
Time Frame: 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 Outcomes
- NRS pain score during movement(morning of the day of discharge (assessed up 7 days))
- 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)
- 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))
- QoR15 score(morning of the day of discharge (assessed up 7 days))
- HCRP(48 hours postoperatively)
- Postoperative adverse reactions(From date of randomization until the date of discharge, assessed up to 7 days)
- Beta-endorphin(48 hours postoperatively)
- Postoperative severe complications(From date of randomization until the date of discharge, assessed up to 7 days)