Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001024437
Ethics application status
Approved
Date submitted
10/12/2015
Date registered
2/08/2016
Date last updated
2/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of continuous preperitoneal infusion of ropivacaine as postoperative analgesia in patients undergoing major abdominopelvic surgeries for resection of tumours
Scientific title
The effect of continuous preperitoneal infusion of ropivacaine as postoperative analgesia in patients undergoing major abdominopelvic surgeries for resection of tumours
Secondary ID [1] 288112 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The problem studied is pain after major abdominal and pelvic surgeries resection of tumours 296984 0
Condition category
Condition code
Cancer 298887 298887 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients will be divided into two groups .The first groups will receive continuous epidural infusion for analgesia and the second groups will receive continuous preperitoneal infusion for analgesia. The intervention group is the preperitoneal group in which a multiholed catheter will be placed by surgeon in the preperitoneal space at the end of surgery giving ropivacaine 0.5% 5ml/h by continuous infusion for 48 hours postoperative after giving bolus dose of 15 ml of lidocaine 2%
Intervention code [1] 293421 0
Treatment: Drugs
Comparator / control treatment
After resection of abdominal or pelvic tumours patients will be randomaly divided into two equal groups .The first group will have an epidural catheter as a sole of postoperative analgesia .While the second group will have continuous preperitonial catheter as an alternative analgesia. The comparator group will have epidural catheter giving 15 ml of xylocaine 2% as bolus dose followed by ropivacaine continuous infusion 0.5% 5ml/h for 48 hours postoperative
Control group
Active

Outcomes
Primary outcome [1] 296819 0
postoperative pain as measured by visual analogue score


Timepoint [1] 296819 0
immediate after surgery,1h,2h,4h,6h,8h,12h,18h,and24h,48h,and lastly 72h
Primary outcome [2] 298923 0
total analgesic consumption assessed by patients medical charts
Timepoint [2] 298923 0
after 48 hours
Secondary outcome [1] 319469 0
heart rate measured by ECG,
Timepoint [1] 319469 0
immediate postoperative,1h,2h,4h,6h,8h,10h,12h,18h,24h,48h,72h
Secondary outcome [2] 323928 0
blood pressure assessed using a sphygmomanomerer
Timepoint [2] 323928 0
immediate postoperative, 1h,2h,h,6h,8h,10h,12h,18h,24h,48h,72h

Eligibility
Key inclusion criteria
1-ASA status 1 ,2,or three
2-aged between 20-80 years old
3-both sexes
4-patients scheduled for abdominal or pelvic resection of tumours
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-patients refusal
2-allergy to local anesthetics
3-bleeding diathesis
4-patients on previous opioid therapy
5- Patients with psychiatric disorders

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
data will be analyzed using SPSS statistics for windows version 20.0.The mean and SD will be calculated for all continuous variables, and in case of normal distribution ,paired or independent test will be carried out ,whereas Mann-Whitney U test will be performed for normally distributed variables. G power program (3.0.10) was used to calculate sample size with priory analysis. VAS .Effect size was chosen as 0.8 (large effect size),alpha error was 0.05 and power of 0.8 was used .The resulted sample size was 20 patients for each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/05/2015
Date of last participant enrolment
Anticipated
Actual
1/12/2015
Date of last data collection
Anticipated
1/03/2016
Actual
1/05/2016
Sample size
Target
40
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 7402 0
Egypt
State/province [1] 7402 0

Funding & Sponsors
Funding source category [1] 292966 0
Self funded/Unfunded
Name [1] 292966 0
REEM ABDEL RAOUF EL SHARKAWY
Country [1] 292966 0
Primary sponsor type
Individual
Name
reem abdelraouf el sharkawy
Address
faculty of medicine Mansoura university,Mansoura ,Egypt
works as a lecture of anesthesia and surgical intensive care unit in Mansoura university Hospital
Country
Egypt
Secondary sponsor category [1] 291738 0
None
Name [1] 291738 0
Address [1] 291738 0
Country [1] 291738 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294003 0
Medical Research Ethics Committee in Faculty of Medicine ,Mansoura University
Ethics committee address [1] 294003 0
FACULTY OF MEDICINE ,MANSOURA UNIVERSITY ,EL GOMHURIA STREET ,DAKAHLIA GOVERNORATE 35516EL
Ethics committee country [1] 294003 0
Egypt
Date submitted for ethics approval [1] 294003 0
Approval date [1] 294003 0
15/05/2015
Ethics approval number [1] 294003 0
R/15.05.03

Summary
Brief summary
Postoperative pain after major abdoiminal and pelvic operation is a challenging issue. the ideal method of pain control is by inserting epidural catheter. But preperitonial catheter insertion is a new technique .So this study will be conducted to compare between two different techniques in control of pain postoperative.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62086 0
Dr reem abdelraouf el sharkawy
Address 62086 0
Faculty of Medicine, Mansoura University ,Mansoura , Dakahlia governorate 35516
Country 62086 0
Egypt
Phone 62086 0
+201006151100
Fax 62086 0
Email 62086 0
reemraouf64@gmail.com
Contact person for public queries
Name 62087 0
Dr reem abdel raouf el sharkawy
Address 62087 0
Faculty of Medicine, Mansoura University, Mansoura ,Dakahlia governorate 35516
Country 62087 0
Egypt
Phone 62087 0
+201006151100
Fax 62087 0
Email 62087 0
reemraouf64@gmail.com
Contact person for scientific queries
Name 62088 0
Dr reem abdel raouf el sharkawy
Address 62088 0
Faculty of Medicine, Mansoura University,Mansoura, Dakahlia governorate 35516
Country 62088 0
Egypt
Phone 62088 0
+201006151100
Fax 62088 0
Email 62088 0
reemraouf64@gmail.com

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

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