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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019779
Receipt No. R000022842
Scientific Title Assessing analgesia in single and repeated administrations of acetaminophen for postoperative pain after spine surgery
Date of disclosure of the study information 2015/11/16
Last modified on 2019/04/03

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Basic information
Public title Assessing analgesia in single and repeated administrations of acetaminophen for postoperative pain after spine surgery
Acronym Repeated vs single administrations of acetaminophen (spine surgery)
Scientific Title Assessing analgesia in single and repeated administrations of acetaminophen for postoperative pain after spine surgery
Scientific Title:Acronym Repeated vs single administrations of acetaminophen (spine surgery)
Region
Japan

Condition
Condition Desease of spine
Classification by specialty
Orthopedics Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We assess the effects and adverse effects of single and repeated administrations of acetaminophen for postoperative pain management after spine surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes 1) postoperative pain score (numerical rating scale: NRS) at 2, 4 hour at postoperative day (POD) 0, AAM and PM at POD 1 and 2

2) supplemental analgesia for 2 days
Key secondary outcomes 1) postoperative nausea and vomiting for 2 days

2) satisfaction of the patient using NRS at POD 2

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -investigator(s) and 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
Interventions/Control_1 Patients in group R were administrated IV 1 g acetaminophen 4 times per day for 2 days postoperatively.
Interventions/Control_2 Patients in group S were administrated IV 1 g acetaminophen only once at the end of surgery.
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
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with American Society of Anesthesiologists physical status 1-2 who were scheduled to undergo elective spine surgery under general anesthesia.
Key exclusion criteria 1) Weighed < 40 or > 100 kg
2) Pregnancy
3) Having neurological, cardiovascular, and respiratory complications.
4) Allergy to amide local anesthetics or opioids4
5) Psychoactive medications
6) Hepatic or renal failure
7) Inability to understand the pain scale
8) Not obtained informed consent
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukitoshi Niiyama
Organization Sapporo Medical University, School of Medicine
Division name Department of Anesthesiology
Zip code
Address South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL 011-611-2111(3568)
Email niiyama@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukitoshi Niiyama
Organization Sapporo Medical University, School of Medicine
Division name Department of Anesthesiology
Zip code
Address South 1 West 16 Chuo-ku, Sapporo, Hokkaido 060-8556, Japan
TEL 011-611-2111(3568)
Homepage URL
Email niiyama@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University, School of Medicine
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
Address
Tel
Email

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
2015 Year 11 Month 16 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
2015 Year 11 Month 16 Day
Date of IRB
2014 Year 02 Month 13 Day
Anticipated trial start date
2014 Year 02 Month 13 Day
Last follow-up date
2016 Year 01 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 13 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022842

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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