UMIN-CTR Clinical Trial

Basic information
Public title	Analgesic effect of continuous transversus abdominis plane block for renal transplant recipients.
Acronym	Analgesic effect of continuous transversus abdominis plane block for renal transplant recipients.
Scientific Title	Analgesic effect of continuous transversus abdominis plane block for renal transplant recipients.
Scientific Title:Acronym	Analgesic effect of continuous transversus abdominis plane block for renal transplant recipients.
Region	Japan

Condition
Condition	Patients who are scheduled for renal transplant from living donor
Classification by specialty	Urology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will test the hypothesis that the continuous transversus abdominis plane block may decrease postoperative pain compared with conventional multimodal analgesia including IVPCA fentanyl for renal transplant recipients who may receive perioperative anticoagulation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cumulative fentanyl consumption in 48hours postoperation
Key secondary outcomes	1. Visual Analogue Scale (VAS) pain scores at rest and at mobilization after 4, 16, 24, 40 and 48hours postoperation. 2. Incidence of nausea and vomitting

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Device,equipment Maneuver
Interventions/Control_1	Patients will receive a standardized general anesthetic with multimodal analgesia including IV-PCA fentanyl and ultrasound-guided transversus abdominis plane block. They will receive analgesia through a catheter placed into transversus abdominis plane and connected to levobupivacaine infusion postoperatively.
Interventions/Control_2	Patients will receive a standardized general anesthetic with conventional multimodal analgesia including IV-PCA fentanyl. They will not receive transversus abdominis plane block.
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	20 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients who are scheduled for renal transplant from living donor in Osaka University Hospital 2. Patients who may receive anticoagulantion and cannot receive epidural anesthesia 3. Patients who can give written informed consent
Key exclusion criteria	1. Patinets who are allergic to any medication used in the study 2. Pantients who have abdominal pain before surgery or use analgetic drugs for chronic pain 3. Patients who have severe paralysis or severe neurologic disease 4. Patients who are regarded ineligible by doctors with any other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Sho Middle name Carl Last name Shibata
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	565-0871
Address	E7-2-2, Yamadaoka, Suita, Osaka
TEL	06-6879-3133
Email	karlshibata@pain.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Akihiko Middle name Last name Maeda
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	565-0871
Address	E7-2-2, Yamadaoka, Suita, Osaka
TEL	06-6879-3133
Homepage URL
Email	amaeda@anes.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Hospital
Institute
Department

Funding Source
Organization	None
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	Medical Center for Translational Research Osaka University Hospital
Address	2-15, Yamadaoka, Suita, Osaka
Tel	06-6879-6090
Email	shiken@hp.crc.osaka-u.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 03 Month 03 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
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	Terminated
Date of protocol fixation	2014 Year 03 Month 03 Day
Date of IRB	2014 Year 12 Month 16 Day
Anticipated trial start date	2015 Year 01 Month 21 Day
Last follow-up date	2018 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 03 Month 03 Day
Last modified on	2021 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015541