UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029865 |
|---|---|
| Receipt number | R000034111 |
| Scientific Title | Postoperative Pain Management with Continuous Wound Infiltration in Patients undergoing Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/01/31 19:58:11 |
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Basic information
Public title
Postoperative Pain Management with Continuous Wound Infiltration in Patients undergoing Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
Acronym
Postoperative Pain Management with Continuous Wound Infiltration in Patients undergoing Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
Scientific Title
Postoperative Pain Management with Continuous Wound Infiltration in Patients undergoing Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
Scientific Title:Acronym
Postoperative Pain Management with Continuous Wound Infiltration in Patients undergoing Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
Region
| Japan |
Condition
Condition
Adolescent idiopathic scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this clinical trial is to determine whether continuous wound infiltration of local anesthetics reduces postoperative pain in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative morphine consumption within 48h after surgery.
Key secondary outcomes
Pain scores (Numerical Rating Scale, 0-10), sedation scales, incidence of postoperative nausea and vomiting, antiemetic consumption and incidence of pruritus in the 48h after surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Continuous wound infiltration of local anesthetic (48h)
Interventions/Control_2
No interventions
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
| 10 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients (equal to or older than 10 years old and younger than 20 years old) undergoing posterior spinal fusion for adolescent idiopathic scoliosis
Key exclusion criteria
Patients who are contraindicated to any study medications, who cannot answer the questionnaire and patients that the physician deems inappropriate.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morisaki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi, Shinjukuku Tokyo, Japan
TEL
03-3353-1211
morisaki@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Seki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
35 Shinanomachi Shinjukuku, Tokyo Japan
TEL
03-3353-1211
Homepage URL
hseki@a3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding (Department of Anesthesiology, Keio University School of Medicine)
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
Address
Tel
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | 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
| 2017 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2018 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034111
