UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050983 |
|---|---|
| Receipt number | R000058043 |
| Scientific Title | Efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) combined with patient-controlled epidural analgesia (PCEA) for labour analgesia |
| Date of disclosure of the study information | 2023/05/05 |
| Last modified on | 2024/05/17 15:51:45 |
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Basic information
Public title
Efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) combined with patient-controlled epidural analgesia (PCEA) for labour analgesia
Acronym
TEAS combined with PCEA for labour analgesia
Scientific Title
Efficacy and safety of transcutaneous electrical acupoint stimulation (TEAS) combined with patient-controlled epidural analgesia (PCEA) for labour analgesia
Scientific Title:Acronym
TEAS combined with PCEA for labour analgesia
Region
| Asia(except Japan) |
Condition
Condition
Participants were in the active phase of labour at the time. The inclusion criteria were as follows: the fetus must have reached a gestational age of 37 to 42 weeks; the women must have had a normal pregnancy, with vertex presentation, and must have presented cervical dilatation of 3 to 5 cm, with contractions that had initiated and were regular; the women must have demonstrated the ability to communicate verbally.
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of TEAS combined with PCEA for labour analgesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study was the total volume of anesthetic solution consumed in the PCEA device.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Puerperants were placed in the left-lateral position. The puncture point was between L 3 and L 4. After confirming the puncture was correct, a 4 cm epidural catheter was inserted into the cephalic side. First, 4 mL of 1 % lidocaine was given, then observation was conducted for five minutes to determine whether there was a subarachnoid block or anesthetic toxicity. After excluding abnormality by observation, 8 mL of 0.1 % ropivacaine and 0.5 micrograms / mL sufentanil was injected. After the pain was relieved, the analgesia pump was connected, and 100 mL of 0.1 % ropivacaine and 0.5 micrograms / mL sufentanil was given. The input rate was set to 10 mL / h, and the added dose was 3 mL. The added dose interval was 15 minutes. The TEAS group was carried out during labour using TEAS unit with tetrad channels. Each channel was connected to a pair of electrodes placed at bilatered four points of LI 4 (Hegu), PC 6 (Neiguan), SP 6 (Sanyinjiao), and ST 36 (Zusanli), respectively. The frequency of electronic stimulation was changed from 2 Hz to 100 Hz, and the intensity was adjusted to cause a maximum tolerable buzzing or prickling sensation without muscle contractions in subjects.
Interventions/Control_2
Puerperants were placed in the left-lateral position. The puncture point was between L 3 and L 4. After confirming the puncture was correct, a 4 cm epidural catheter was inserted into the cephalic side. First, 4 mL of 1 % lidocaine was given, then observation was conducted for five minutes to determine whether there was a subarachnoid block or anesthetic toxicity. After excluding abnormality by observation, 8 mL of 0.1 % ropivacaine and 0.5 micrograms / mL sufentanil was injected. After the pain was relieved, the analgesia pump was connected, and 100 mL of 0.1 % ropivacaine and 0.5 micrograms / mL sufentanil was given. The input rate was set to 10 mL / h, and the added dose was 3 mL. The added dose interval was 15 minutes. Parturients in the TENS placebo group were also connected to the device, but no electrical stimulation was applied.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Recruited for this study were nulliparous parturients with healthy singleton pregnancies, gestational age >37 weeks, American Society of Anesthesiologists Physical Status II spontaneous onset of labor, no previous poor obstetrical outcome, no experience of pain relief by systemic or epidural anesthesia in a previous delivery, no experience in acupuncture or TEAS for other reasons,active phase of labor with cervical dilation of 3 cm, and painful contractions requiring labor epidural analgesia.
Key exclusion criteria
Patients were excluded if they: (1) had the history of experimental drug allergy; (2) had been diagnosed with other diseases such as preoperative presence of maternal mental, neurological diseases, affecting evaluation of pains and disease conditions; (3) had combined with gestational hypertension, gestational diabetes, gestational thyroid diseases; (4) had taken analgesic drugs or with a history of long-term use of analgesic drugs; (5) had used diazepam, piperazine hydrochloride or other sedative, analgesic drugs in the stages of labor; (6 ) were overweight or low pregnancy weight,body mass index < 18.5 or > 25; (7) were not agree to receive painless labor and not sign the informed consent from; (8) fetal compromise; (9) maternal cutaneous lesions on the application sites such as wound scars, urticaria or insect bites; (10) candidates for vaginal birth after cesarean section; and (11) pacemaker users; (12) absolute contraindications or relative contraindications to spinal anesthesia.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | jie |
| Middle name | |
| Last name | Chen |
Organization
People's Hospital of Chongqing Banan District
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66234145
cjandsh@tmmu.edu.cn
Public contact
Name of contact person
| 1st name | jie |
| Middle name | |
| Last name | Chen |
Organization
People's Hospital of Chongqing Banan District
Division name
Department of Anaesthesiology
Zip code
401320
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing, China
TEL
+81-086-23-66234145
Homepage URL
cjandsh@tmmu.edu.cn
Sponsor or person
Institute
Department of Anaesthesiology, People's Hospital of Chongqing Banan District
Institute
Department
Personal name
Funding Source
Organization
Chongqing health commission, Chongqing science and technology commission, and People's Hospital of Chongqing Banan District
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the People's Hospital of Chongqing Banan District
Address
Yunan Avenue 659, Longzhouwan Street, Banan District, Chongqing 401320, P.R China
Tel
+81-086-23-66291798
409560509@qq.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 05 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058043
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058043
Number of participants that the trial has enrolled
70
Results
N.A.
Results date posted
| 2024 | Year | 05 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N.A.
Participant flow
N.A.
Adverse events
N.A.
Outcome measures
N.A.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 03 | Day |
Last modified on
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058043
