Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000043538
Ethics application status
Approved
Date submitted
25/01/2006
Date registered
27/01/2006
Date last updated
27/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of epidural adenosine and neostigmine on postoperative pain status
Scientific title
A randomised study to evaluate the effect of epidural adenosine and neostigmine in patients undergoing abdominal surgery to improve postoperative pain status.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 1005 0
Condition category
Condition code
Surgery 1081 1081 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Epidural adenosine and neostigmine for 4 hours given as intravenous injections over 12 weeks
Intervention code [1] 866 0
None
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1446 0
Postoperative pain scores
Timepoint [1] 1446 0
Secondary outcome [1] 2575 0
Plasma level of cortisol
Timepoint [1] 2575 0
During and after surgery.

Eligibility
Key inclusion criteria
Patients undergoing lower abdominal surgery for benign gynecological disease.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed envelope assignment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
blocking and sealed envelope assignment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 265 0
Japan
State/province [1] 265 0

Funding & Sponsors
Funding source category [1] 1184 0
Government body
Name [1] 1184 0
Ministry of Education, Science, Sport and Culture of Japan
Country [1] 1184 0
Japan
Primary sponsor type
Individual
Name
Eiji Masaki
Address
Country
Secondary sponsor category [1] 1043 0
Individual
Name [1] 1043 0
Kazuhiro Shoji
Address [1] 1043 0
Country [1] 1043 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35254 0
Address 35254 0
Country 35254 0
Phone 35254 0
Fax 35254 0
Email 35254 0
Contact person for public queries
Name 10055 0
Eiji Masaki
Address 10055 0
Department of Anesthesiology
Saitama Medical School
38 Morohongo Moroyama-cho Iruma-gun
Saitama 350-0451
Country 10055 0
Japan
Phone 10055 0
+81 49 2761270
Fax 10055 0
Email 10055 0
ejmaaki@saitama-med.ac.jp
Contact person for scientific queries
Name 983 0
Eiji Masaki
Address 983 0
Department of Anesthesiology
Saitama Medical School
38 Morohongo Moroyama-cho Iruma-gun
Saitama 350-0451
Country 983 0
Japan
Phone 983 0
+81 49 2761270
Fax 983 0
Email 983 0
ejmasaki@saitama-med.ac.jp

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.