Acupuncture AnalgesiaNCT06795594
Effectiveness of Cheek Acupuncture Therapy for Pain Control After Cesarean Delivery
A study testing cheek acupuncture and sufentanil 2 µg/kg + ondansetron 0.2 mg/kg in people with Acupuncture Analgesia, run by Beijing Tongren Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Acupuncture Analgesia
- What is being tested?
- cheek acupuncture and sufentanil 2 µg/kg + ondansetron 0.2 mg/kg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2025to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, 100730
About this study
Official title: Cheek Acupuncture Therapy Vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
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.
Read the 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
- Being tested
- cheek acupuncture, sufentanil 2 µg/kg + ondansetron 0.2 mg/kg
- Keywords
- Cheek acupuncture therapy, Acupuncture, Cesarean delivery, Pain control, Postoperative pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cheek acupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: sufentanil 2 µg/kg + ondansetron 0.2 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Assess the proportion of severe pain by calculating the ratio of NRS pain scores that are greater than or equal to 6.
Measured: 24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment
NRS 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.
Measured: 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.
Measured: 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.
Measured: morning of the day of discharge (assessed up 7 days)
ISI score
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.
Measured: morning of the day of discharge (assessed up 7 days)
QoR15 score
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.
Measured: morning of the day of discharge (assessed up 7 days)
HCRP
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.
Measured: 48 hours postoperatively
Beta-endorphin
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.
Measured: 48 hours postoperatively
Postoperative adverse reactions
Explore whether cheek acupuncture intervention increases postoperative adverse reactions, including dizziness, abdominal bloating, nausea, vomiting, fatigue and so on.
Measured: From date of randomization until the date of discharge, assessed up to 7 days
Postoperative severe complications
Postoperative severe complications, including pulmonary complications, heart failure, liver dysfunction, kidney dysfunction, coagulation function, SIRS (Systemic Inflammatory Response Syndrome), stroke, and so on.
Measured: From date of randomization until the date of discharge, assessed up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start5 Jan 2025
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acupuncture AnalgesiaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guyan Wang, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795594
- Sponsor's protocol ID
- TREC2024-KY090.R1
- Status last verified
- Jan 2025
- First submitted
- 8 Dec 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cheek Acupuncture Therapy Vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06795594
- Acronym / sponsor ID
- TREC2024-KY090.R1
- Conditions
- Acupuncture Analgesia
- Keywords
- Cheek acupuncture therapy, Acupuncture, Cesarean delivery, Pain control, Postoperative pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cheek Acupuncture group | Experimental | Procedure: cheek acupuncture, Drug: sufentanil 2 µg/kg + ondansetron 0.2 mg/kgEach 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. |
| Control group | Sham comparator | Drug: sufentanil 2 µg/kg + ondansetron 0.2 mg/kgThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cheek acupunctureCheek Acupuncture | Procedure or surgery | Cheek Acupuncture group |
| sufentanil 2 µg/kg + ondansetron 0.2 mg/kgThe 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. | Drug | Cheek Acupuncture group, Control group |
Primary outcome
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.
10 secondary outcomes
the proportion of patients with NRS pain score ≥ 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
Time frame: morning of the day of discharge (assessed up 7 days)
HADS-D score
Time frame: morning of the day of discharge (assessed up 7 days)
ISI score
Time frame: morning of the day of discharge (assessed up 7 days)
QoR15 score
Time frame: morning of the day of discharge (assessed up 7 days)
HCRP
Time frame: 48 hours postoperatively
Beta-endorphin
Time frame: 48 hours postoperatively
Postoperative adverse reactions
Time frame: From date of randomization until the date of discharge, assessed up to 7 days
Postoperative severe complications
Time frame: From date of randomization until the date of discharge, assessed up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guyan Wang study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cheek acupuncture and sufentanil 2 µg/kg + ondansetron 0.2 mg/kg in people with Acupuncture Analgesia, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.