UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032475 |
|---|---|
| Receipt number | R000027092 |
| Scientific Title | Comparison of intrathecal morphine with continuous patient-controlled epidural anesthesia versus intrathecal morphine alone for post-cesarean section analgesia: a randomized controlled trial |
| Date of disclosure of the study information | 2018/05/06 |
| Last modified on | 2020/02/28 15:28:50 |
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Basic information
Public title
Comparison of intrathecal morphine with continuous patient-controlled epidural anesthesia versus intrathecal morphine alone for post-cesarean section analgesia: a randomized controlled trial
Acronym
Comparison of intrathecal morphine with continuous patient-controlled epidural anesthesia versus intrathecal morphine alone for post-cesarean section analgesia: a randomized controlled trial
Scientific Title
Comparison of intrathecal morphine with continuous patient-controlled epidural anesthesia versus intrathecal morphine alone for post-cesarean section analgesia: a randomized controlled trial
Scientific Title:Acronym
Comparison of intrathecal morphine with continuous patient-controlled epidural anesthesia versus intrathecal morphine alone for post-cesarean section analgesia: a randomized controlled trial
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine that the combined use of PCEA and spinal anesthesia with intrathecal morphine may have an advantage in postoperative analgesia following caesarean section compared to intrathecal morphine and single shot spinal anesthesia alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is postoperative pain as measured by NRS at 12 hours after intrathecal administration of morphine at rest and during mobilization
Key secondary outcomes
Secondary outcomes are NRS and Bromage score at 4, 8, 24, 48 hours after intrathecal administration of morphine at rest and during mobilization, the number of patients who requested rescue analgesics, the number of requests for rescue analgesics per patient, the interval time before the first request of rescue analgesics, the incidence of delayed ambulation, and the incidence of requested treatment for pruritus and postoperative nausea and vomiting (PONV) during the first 24 hours after intrathecal administration of morphine.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
spinal anesthesia and epidural anesthesia
Interventions/Control_2
spinal anesthesia
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1.The case of the American Society of Anesthesiologists (ASA) physical status classification scale I and II and that regional anesthesia is thought to be adaptated.
2.The case that a written agreement is provided about the participation in this study.
Key exclusion criteria
We excluded patients with contraindications for spinal or epidural anesthesia due to hemodynamic, infectious, hemostatic, neurological statuses, and medication use. In addition, we excluded cases of which we were unable to obtain informed consent such as extremely emergent caesarean sections and cases of which general anesthesia was selected for reasons such as urgency or prediction of massive hemorrhage.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Iwasaki |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
Midorigaoka-higashi, Asahikawa-shi, Hokkaido 078-8510,
TEL
0166-68-2583
iwasakih@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Sato |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
Midorigaoka-higashi, Asahikawa-shi, Hokkaido 078-8510
TEL
0166-68-2583
Homepage URL
izumihata323@yahoo.co.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Kushiro Red Cross Hospital
Address
21-14, Shinei-cho, Kushiro, Hokkaido, Japan
Tel
0154-22-7171
nakagoshi@kushiro.jrc.or.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
| 2018 | Year | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
46
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 05 | Day |
Last modified on
| 2020 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027092
