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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032475
Receipt No. 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

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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
Obsterics 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
Email 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
Email izumihata323@yahoo.co.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027092

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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