Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001161617
Ethics application status
Approved
Date submitted
20/10/2014
Date registered
4/11/2014
Date last updated
24/04/2019
Date data sharing statement initially provided
24/04/2019
Date results provided
24/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of Intraperitoneal Ropivacaine in Laparoscopic Appendicectomy: A prospective, double blinded randomised control study
Scientific title
The effect of intraperitoneal Ropivacaine on post-laparoscopic pain in appendicectomy patients compared with the effect of intraperitoneal normal saline.
Secondary ID [1] 285524 0
Nil
Universal Trial Number (UTN)
U1111-1163-0786
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appendicitis
 293338 0
Abdominal pain 293339 0
Condition category
Condition code
Surgery 293604 293604 0 0
Surgical techniques
Anaesthesiology 293638 293638 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intraperitoneal injection of 0.5ml per kilogram of 0.2% Ropivacaine after the insertion of suprapubic port and another 0.5ml per kilogram of the same solution at the end of laparoscopic appendicectomy.
Intervention code [1] 290467 0
Treatment: Drugs
Comparator / control treatment
Intraperitoneal injection of 0.5ml per kilogram of Normal Saline after the insertion of suprapubic port and another 0.5ml per kilogram of the same solution at the end of laparoscopic appendicectomy.
Control group
Placebo

Outcomes
Primary outcome [1] 293415 0
Total amount of Intravenous Fentanyl used after operation. Including recovery period and Patient controlled intravenous analgesia used.
Timepoint [1] 293415 0
1. Immediate post op period (0-4 hours).
2. Up to 16 hours post operation.
Primary outcome [2] 293453 0
Verbal response regarding presence or absence of postoperative nausea and vomiting
Timepoint [2] 293453 0
Up to 16 hours post operation.
Divided into immediate period (0-4 hours) and from 4-16 hours.
Primary outcome [3] 293454 0
Verbal response regarding presence or absence of postoperative shoulder tip pain.
Timepoint [3] 293454 0
Up to 16 hours post operation.
Divided into immediate period (0-4 hours) and from 4-16 hours.
Secondary outcome [1] 310981 0
Length of hospital stay. Data collected from patient medical records.
Timepoint [1] 310981 0
At patient discharge

Eligibility
Key inclusion criteria
All patients undergoing laparoscopic appendicectomy at Armadale Hospital
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Medical or psychiatric conditions that compromise patient’s ability to give informed consent
2. Pregnant or breast feeding
3. Allergies to paracetamol, fentanyl or ropivacaine.
4. Liver failure
5. Conversion from laparoscopic surgery to open surgery
6. Presence of faecal peritonitis
7. ASA III
8. Iatrogenic perforation
9. Chronic pain syndrome
10. Operative time more than 2 hours.
11. Drain insertion
12. Weight >100kg

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)
The patients are recruited during the consenting process for laparoscopic appendicectomy.

The randomisation and blinding is achieved by the computer software from the Armadale Pharmacy that randomly assigns a blinded solution in the form of 50ml sterile syringes (can have maximum 3 syringes per patient) labelled as number 1-128. These blinded solutions will contain 64 as placebo saline and the other 64 as 0.2% Ropivicaine. The pharmacy will blind the labeling hence blinding both the surgeon and anaesthetist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software from the Armadale Pharmacy that randomly assigns a blinded solution in the form of 50mls sterile syringes (can have maximum 3 syringes per patient) labelled as number 1-128. These blinded solutions will contain 64 as placebo saline and the other 64 as 0.2% Ropivacaine.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size determined by power study approximately 100. For a 50% difference between the post-operative analgesic consumption in the control and treatment group would be of interest. Assuming a one sided significance of 0.05 and a power of 0.8, a total of 51 patients per group with a total sample size of 102 for a one tailed test and for two tailed test then the recommendation is 128 patients in total.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2015
Actual
6/04/2015
Date of last participant enrolment
Anticipated
Actual
4/08/2017
Date of last data collection
Anticipated
Actual
4/08/2017
Sample size
Target
128
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3060 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment postcode(s) [1] 8830 0
6112 - Armadale

Funding & Sponsors
Funding source category [1] 290122 0
Self funded/Unfunded
Name [1] 290122 0
Country [1] 290122 0
Primary sponsor type
Hospital
Name
Armadale and Kelmscott Memorial Hospital
Address
3056 Albany Highway Armadale WA 6112
Country
Australia
Secondary sponsor category [1] 288837 0
None
Name [1] 288837 0
Address [1] 288837 0
Country [1] 288837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291834 0
Human Research Ethics Committee South Metropolitan Health
Ethics committee address [1] 291834 0
Ethics committee country [1] 291834 0
Australia
Date submitted for ethics approval [1] 291834 0
10/10/2014
Approval date [1] 291834 0
29/12/2014
Ethics approval number [1] 291834 0
14/74

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

Contacts
Principal investigator
Name 52214 0
Dr Yang Yang Huang
Address 52214 0
Department of General Surgery
Armadale Health Service
3056 Albany Hwy, Armadale WA 6112
Country 52214 0
Australia
Phone 52214 0
+61040299063
Fax 52214 0
Email 52214 0
[email protected]
Contact person for public queries
Name 52215 0
Yang Yang Huang
Address 52215 0
Department of General Surgery
Armadale Health Service
3056 Albany Hwy, Armadale WA 6112
Country 52215 0
Australia
Phone 52215 0
+61 8 9391 2000
Fax 52215 0
Email 52215 0
[email protected]
Contact person for scientific queries
Name 52216 0
Yang Yang Huang
Address 52216 0
Department of General Surgery
Armadale Health Service
3056 Albany Hwy, Armadale WA 6112
Country 52216 0
Australia
Phone 52216 0
+61 8 9391 2000
Fax 52216 0
Email 52216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not consented.


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.