UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013695 |
|---|---|
| Receipt number | R000015987 |
| Scientific Title | JAPAN, Randomized, Parallel-Group Comparison Study on Clinical Efficacy of Acupuncture for Post-Cesarean Pruritus due to Intrathecal Morphine |
| Date of disclosure of the study information | 2014/04/12 |
| Last modified on | 2021/01/16 21:50:20 |
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Basic information
Public title
JAPAN, Randomized, Parallel-Group Comparison Study on Clinical Efficacy of Acupuncture for Post-Cesarean Pruritus due to Intrathecal Morphine
Acronym
JEAPCP-ITM study
Scientific Title
JAPAN, Randomized, Parallel-Group Comparison Study on Clinical Efficacy of Acupuncture for Post-Cesarean Pruritus due to Intrathecal Morphine
Scientific Title:Acronym
JEAPCP-ITM study
Region
| Japan |
Condition
Condition
postoperative state of cesarean section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intrathecal opioid for post-cesarean analgesia has been recommended because of its efficacy and possibility to early postoperative ambulation. Morphine. water-soluble strong opioid, provides extended analgesia after intrathecal administration and is used in many clinical situations. However, intrathecal morphine causes pruritus and this complication make sometimes the post-cesarean patients mothering difficult. On the other hand, the efficacy of acupuncture fore reducing postoperative pruritus after general surgery has been reported.
The purpose of this study is elucidate the efficacy of acupuncture for reducing post-cesarean pruritus administrated morphine intrathecally.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of postoperative pruritus
Key secondary outcomes
Incidence of postoperative nausea and vomiting
Numeric Rating Scale for postoperative pain
Incidence of drug treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Thumb Tack Needles
Interventions/Control_2
Sham
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1) Parturients who will receive cesarean section
2) Performed spinal anesthesia and administered morphine intrathecally
3) Parturients must have oral communication ability; can provide written informed consent signed by herself under her free will after receiving full explanation of the study.
Key exclusion criteria
Parturients who do not consent to the nature of the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yusue |
| Middle name | |
| Last name | Mazda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Division of Obstetric Anesthesia
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3654
mazda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Mazda |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Division of Obstetric Anesthesia
Zip code
350-8550
Address
1981 Kamoda, Kawagoe, Saitama
TEL
049-228-3654
Homepage URL
mazda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical CenterIRB
Address
1981 Kamoda, Kawagoe, Saitama
Tel
049-228-3411
smcrinri@saitama-med.ac.jp
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
| 2014 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://www.obstetanesthesia.com/article/S0959-289X(18)30171-7/fulltext
Number of participants that the trial has enrolled
30
Results
The postoperative incidence of pruritist was 67% vs. 67% in each groups. Likewise, the incidence of intraoperative pruritis was the same.
Results date posted
| 2021 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 07 | Month | 27 | Day |
Baseline Characteristics
The present trial included 30 parturients aged 18-50 years with an American Society of Anesthesiologists physical status of I or II who were scheduled for cesarean section under spinal anesthesia (SA) or combined spinal epidural anesthesia (CSEA) at term (> 37 weeks gestation) from October 2015 to March 2016. The trial was conducted at the Saitama Medical Center, Kawagoe, Japan, which is a tertiary perinatal center. Exclusion criteria were: hypertensive disorders, diabetes mellitus, cardiovascular diseases, neurological diseases, coagulopathies, severe fetal anomalies, skin diseases, pruritus during pregnancy, participation refusal, and the performance of the cesarean section at a time when the acupuncturists were unavailable.
Participant flow
Patients were fasted for at least 8 hours before arrival at the operating room. Standard monitoring was performed, including non-invasive blood pressure measurement, electrocardiography, and pulse oximetry. An anesthesiologist inserted a 20 G or 18 G intravenous cannula into a forearm vein, and then administered 10 mg of metoclopramide intravenously. Co-hydration with 0.5-1 L of 6% hydroxyethyl starch 130/0.4 in isotonic saline was administered until delivery. The method of anesthesia (SA or CSEA) was selected at the discretion of the anesthesiologist based on the expected duration of surgery. With the patient in the right lateral decubitus position, neuraxial anesthesia was performed at the L2/3 or L3/4 interspace using a 25 G or 27 G Whitacre spinal needle with an introducer (Unisis Corporation, Tokyo, Japan) for SA, or an 18 G Touhy needle with a 27 G Whitacre spinal needle (CSEcure, Smith Medical Japan, Tokyo, Japan) for CSEA. Both types of anesthesia were induced by intrathecal administration of hyperbaric bupivacaine (12 mg), fentanyl (10 mcg), and preservative-free morphine (150 mcg). In CSEA, the epidural catheter was advanced 3-5 cm in the cephalad direction and fixed without a test dose. Left uterine displacement was continued from induction of anesthesia to delivery of the neonate, and supplemental oxygen was only administered when SpO2 was < 95%. Blood pressure was measured every minute until delivery, and a vasopressor was administered when the mean arterial pressure fell below 70 mmHg or systolic blood pressure fell below 100 mmHg15. Vasopressor selection was dependent on maternal heart rate; phenylephrine (100 mcg) was administered as an intravenous bolus if the maternal heart rate was equal to or greater than 60 bpm, while ephedrine (5 mg) was administered if the maternal heart rate was less than 60 bpm. Vasopressor administration was repeated as needed to restore blood pressure. After the delivery of the neonate, a blinded obstetrician obtained umbilical arterial blood by the double-clamp method after blood gas analysis, and a blinded neonatologist assessed the Apgar score at 1 and 5 minutes.
Adverse events
None
Outcome measures
The primary outcome was the occurrence of pruritus within 24 hours postoperatively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 11 | Day |
Last modified on
| 2021 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015987
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/01/16 | 研究計画書：円皮鍼・掻痒.docx |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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