Cesarean SectionNCT04879212
Clinical Effect of Electroacupuncture on Postoperative Analgesia After Cesarean Sectionanalgesia After Cesarean Section
A study testing PCIA +Acupuncture group: in people with Cesarean Section, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Cesarean section is one of the most common operations in obstetrics. A survey shows that the rate of cesarean section in China is more than 40%, and even more than 70%. At present, the main analgesia methods after cesarean section are: patient controlled intravenous analgesia (PCIA), single injection of opioids into… Read more about this study
- Who is it for?
- Ages 22 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section
- What is being tested?
- PCIA +Acupuncture group:
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 22 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 22-40 years old, gestational age 31-42 weeks;
- There was no electroacupuncture treatment before cesarean section;
- No food and drug allergy, no long-term use of analgesics; .They agreed and only participated in one clinical project and signed the informed consent form.
Who cannot join
- Suffering from complications after cesarean section, such as massive hemorrhage, etc;
- There was a history of chronic pain before operation;
- History of cognitive impairment;
- Skin lesions such as ulcers and eczema at the needling site are not suitable for needling;
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
About this study
Official title: Clinical Effect of Electroacupuncture Combined With Fentanyl Patient-controlled Intravenous Analgesia on Postoperative Analgesia After Cesarean Section
Cesarean section is one of the most common operations in obstetrics. A survey shows that the rate of cesarean section in China is more than 40%, and even more than 70%. At present, the main analgesia methods after cesarean section are: patient controlled intravenous analgesia (PCIA), single injection of opioids into spinal canal, nerve block technique, combined or single oral drug for postoperative analgesia, etc. All kinds of postoperative analgesia methods have their own advantages and disadvantages. At present, PCIA is widely used in clinic, but it can cause side effects such as pruritus, nausea, vomiting and respiratory depression. Therefore, it is urgent to find a safe, effective, economic, reliable and operable treatment of PCIA for postoperative analgesia after cesarean section. Electroacupuncture is a technology combining traditional acupuncture and modern electrotherapy, which has a significant effect on acute and chronic pain. Studies have confirmed that electroacupuncture can help parturient women to deliver and relieve pain after delivery. However, there are few studies on the analgesic effect of Electroacupuncture on pain after cesarean section, and there are a few reports on wrist ankle acupuncture. On the basis of our previous research, we found that the frequency of 20 / 100Hz and 2Hz were the best for EA analgesia, and the density wave. Electroacupuncture is an ideal choice for PCIA analgesia after cesarean section because of its low price, rapid onset, long duration and no adverse drug reactions. "Zusanli" belongs to the stomach meridian of Foot Yangming. It is the meridian of multi Qi and multi blood. It has the effect of regulating meridians and collaterals, dredging Qi and blood, and treating various kinds of abdominal pain. Sanyinjiao belongs to the spleen meridian of foot Taiyin, which is the meeting of foot Taiyin, Jueyin and Shaoyin. Since ancient times, Sanyinjiao has been a commonly used acupoint to relieve labor pain. Modern studies have also shown that Sanyinjiao can relieve uterine contraction pain by relieving uterine smooth muscle spasm, improving the state of uterine ischemia and hypoxia, releasing a variety of central analgesic substances and so on Spleen and blood, liver tonifying and kidney tonifying. Therefore, on the basis of conventional PCIA analgesia combined with electroacupuncture at Zusanli and Sanyinjiao, we may play an auxiliary role in analgesia for puerpera after cesarean section.
Read the detailed description
Electroacupuncture is an ideal choice for PCIA analgesia after cesarean section because of its low price, rapid onset, long duration and no adverse drug reactions. "Zusanli" belongs to the stomach meridian of Foot Yangming. It is the meridian of multi Qi and multi blood. It has the effect of regulating meridians and collaterals, dredging Qi and blood, and treating various kinds of abdominal pain. Sanyinjiao belongs to the spleen meridian of foot Taiyin, which is the meeting of foot Taiyin, Jueyin and Shaoyin. Since ancient times, Sanyinjiao has been a commonly used acupoint to relieve labor pain. Modern studies have also shown that Sanyinjiao can relieve uterine contraction pain by relieving uterine smooth muscle spasm, improving the state of uterine ischemia and hypoxia, releasing a variety of central analgesic substances and so on Spleen and blood, liver tonifying and kidney tonifying. Therefore, on the basis of conventional PCIA analgesia combined with electroacupuncture at Zusanli and Sanyinjiao, we may play an auxiliary role in analgesia for puerpera after cesarean section.
- Conditions
- Cesarean Section
- Being tested
- PCIA +Acupuncture group:
- Keywords
- Analgesia, Electroacupuncture
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIA +Acupuncture group:Other
Also called PCIA +2 Hz Electroacupuncture group, PCIA +20/100 Hz Electroacupuncture group
Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6)
| Study group | Role | What they receive |
|---|---|---|
| PCIA +Acupuncture group | Experimental | Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6) to connect Huatuo brand electroacupuncture apparatus, but no electricity. Acupuncture was given once a day. PCIA（patient controlled intravenous analgesia）. Receives: Other: PCIA +Acupuncture group: |
| PCIA +2 Hz Electroacupuncture group | Experimental | Acupuncture bilateral Zusanli (ST36) and Sanyinjiao (SP6) to connect Huatuo brand electroacupuncture apparatus, and the ipsilateral Zusanli, Sanyinjiao were respectively connected as a loop. The parameters of electroacupuncture were set as 2Hz, continuous wave, 25min, and current intensity was 0.1-5.0mA. Acupuncture was given once a day. Receives: Other: PCIA +Acupuncture group: |
| PCIA +20/100 Hz Electroacupuncture group | Experimental | Acupuncture bilateral Zusanli (ST36) and Sanyinjiao (SP6) to connect Huatuo brand electroacupuncture apparatus, and the ipsilateral Zusanli, Sanyinjiao were respectively connected as a loop. The parameters of electroacupuncture were set as 20 / 100Hz, density wave, 25min, and current intensity was 0.1-5.0mA. Acupuncture was given once a day. Receives: Other: PCIA +Acupuncture group: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of times PCIA is used
Number of times PCIA is used
Measured: 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. PCIA +Acupuncture group 2. PCIA +2 Hz Electroacupuncture group 3. PCIA +20/100 Hz Electroacupuncture group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Jin, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879212
- Sponsor's protocol ID
- 2020-1029
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Electroacupuncture Combined With Fentanyl Patient-controlled Intravenous Analgesia on Postoperative Analgesia After Cesarean Section
- ClinicalTrials.gov ID
- NCT04879212
- Acronym / sponsor ID
- 2020-1029
- Conditions
- Cesarean Section
- Keywords
- Analgesia, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 May 2021 (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.
Cesarean section is one of the most common operations in obstetrics. A survey shows that the rate of cesarean section in China is more than 40%, and even more than 70%. At present, the main analgesia methods after cesarean section are: patient controlled intravenous analgesia (PCIA), single injection of opioids into spinal canal, nerve block technique, combined or single oral drug for postoperative analgesia, etc. All kinds of postoperative analgesia methods have their own advantages and disadvantages. At present, PCIA is widely used in clinic, but it can cause side effects such as pruritus, nausea, vomiting and respiratory depression. Therefore, it is urgent to find a safe, effective, economic, reliable and operable treatment of PCIA for postoperative analgesia after cesarean section. Electroacupuncture is a technology combining traditional acupuncture and modern electrotherapy, which has a significant effect on acute and chronic pain. Studies have confirmed that electroacupuncture can help parturient women to deliver and relieve pain after delivery. However, there are few studies on the analgesic effect of Electroacupuncture on pain after cesarean section, and there are a few reports on wrist ankle acupuncture. On the basis of our previous research, we found that the frequency of 20 / 100Hz and 2Hz were the best for EA analgesia, and the density wave. Electroacupuncture is an ideal choice for PCIA analgesia after cesarean section because of its low price, rapid onset, long duration and no adverse drug reactions. "Zusanli" belongs to the stomach meridian of Foot Yangming. It is the meridian of multi Qi and multi blood. It has the effect of regulating meridians and collaterals, dredging Qi and blood, and treating various kinds of abdominal pain. Sanyinjiao belongs to the spleen meridian of foot Taiyin, which is the meeting of foot Taiyin, Jueyin and Shaoyin. Since ancient times, Sanyinjiao has been a commonly used acupoint to relieve labor pain. Modern studies have also shown that Sanyinjiao can relieve uterine contraction pain by relieving uterine smooth muscle spasm, improving the state of uterine ischemia and hypoxia, releasing a variety of central analgesic substances and so on Spleen and blood, liver tonifying and kidney tonifying. Therefore, on the basis of conventional PCIA analgesia combined with electroacupuncture at Zusanli and Sanyinjiao, we may play an auxiliary role in analgesia for puerpera after cesarean section.
Detailed description
Electroacupuncture is an ideal choice for PCIA analgesia after cesarean section because of its low price, rapid onset, long duration and no adverse drug reactions. "Zusanli" belongs to the stomach meridian of Foot Yangming. It is the meridian of multi Qi and multi blood. It has the effect of regulating meridians and collaterals, dredging Qi and blood, and treating various kinds of abdominal pain. Sanyinjiao belongs to the spleen meridian of foot Taiyin, which is the meeting of foot Taiyin, Jueyin and Shaoyin. Since ancient times, Sanyinjiao has been a commonly used acupoint to relieve labor pain. Modern studies have also shown that Sanyinjiao can relieve uterine contraction pain by relieving uterine smooth muscle spasm, improving the state of uterine ischemia and hypoxia, releasing a variety of central analgesic substances and so on Spleen and blood, liver tonifying and kidney tonifying. Therefore, on the basis of conventional PCIA analgesia combined with electroacupuncture at Zusanli and Sanyinjiao, we may play an auxiliary role in analgesia for puerpera after cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1. PCIA +Acupuncture group 2. PCIA +2 Hz Electroacupuncture group 3. PCIA +20/100 Hz Electroacupuncture group
| Arm | Type | Receives |
|---|---|---|
| PCIA +Acupuncture group | Experimental | Other: PCIA +Acupuncture group:Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6) to connect Huatuo brand electroacupuncture apparatus, but no electricity. Acupuncture was given once a day. PCIA（patient controlled intravenous analgesia）. |
| PCIA +2 Hz Electroacupuncture group | Experimental | Other: PCIA +Acupuncture group:Acupuncture bilateral Zusanli (ST36) and Sanyinjiao (SP6) to connect Huatuo brand electroacupuncture apparatus, and the ipsilateral Zusanli, Sanyinjiao were respectively connected as a loop. The parameters of electroacupuncture were set as 2Hz, continuous wave, 25min, and current intensity was 0.1-5.0mA. Acupuncture was given once a day. |
| PCIA +20/100 Hz Electroacupuncture group | Experimental | Other: PCIA +Acupuncture group:Acupuncture bilateral Zusanli (ST36) and Sanyinjiao (SP6) to connect Huatuo brand electroacupuncture apparatus, and the ipsilateral Zusanli, Sanyinjiao were respectively connected as a loop. The parameters of electroacupuncture were set as 20 / 100Hz, density wave, 25min, and current intensity was 0.1-5.0mA. Acupuncture was given once a day. |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 22-40 years old, gestational age 31-42 weeks;
- There was no electroacupuncture treatment before cesarean section;
- No food and drug allergy, no long-term use of analgesics; .They agreed and only participated in one clinical project and signed the informed consent form.
Key exclusion criteria (4 listed)
- Suffering from complications after cesarean section, such as massive hemorrhage, etc;
- There was a history of chronic pain before operation;
- History of cognitive impairment;
- Skin lesions such as ulcers and eczema at the needling site are not suitable for needling;
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 |
|---|---|---|
| PCIA +Acupuncture group:Also: PCIA +2 Hz Electroacupuncture group, PCIA +20/100 Hz Electroacupuncture groupAcupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6) | Other | PCIA +2 Hz Electroacupuncture group, PCIA +20/100 Hz Electroacupuncture group, PCIA +Acupuncture group |
Primary outcome
Number of times PCIA is used
Time frame: 48 hours after operation
Number of times PCIA is used
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 21 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
Not yet recruiting
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
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Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
Ying Jin principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCIA +Acupuncture group: in people with Cesarean Section, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 4 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 21 Sep 2022. 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. 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?
Number of times PCIA is used (time frame: 48 hours after operation). 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 21 Sep 2022.