Clinical Effect of Electroacupuncture on Postoperative Analgesia After Cesarean Sectionanalgesia After Cesarean Section

September 17, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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）.
Other: PCIA +Acupuncture group:
Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6)
Other Names:
  • PCIA +2 Hz Electroacupuncture group
  • PCIA +20/100 Hz Electroacupuncture group
Experimental: PCIA +2 Hz Electroacupuncture 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.
Other: PCIA +Acupuncture group:
Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6)
Other Names:
  • PCIA +2 Hz Electroacupuncture group
  • PCIA +20/100 Hz Electroacupuncture group
Experimental: PCIA +20/100 Hz Electroacupuncture 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.
Other: PCIA +Acupuncture group:
Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6)
Other Names:
  • PCIA +2 Hz Electroacupuncture group
  • PCIA +20/100 Hz Electroacupuncture group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of times PCIA is used
Time Frame: 48 hours after operation
Number of times PCIA is used
48 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Ying Jin, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 18, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 17, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-1029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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