UMIN-CTR Clinical Trial

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