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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04879212
Other study ID # 2020-1029
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2021

Study information

Verified date April 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 158
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 22 Years to 40 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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;

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PCIA +Acupuncture group:
Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6)

Locations

Country Name City State
China 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of times PCIA is used Number of times PCIA is used 48 hours after operation
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