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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02785276




Registration number
NCT02785276
Ethics application status
Date submitted
23/05/2016
Date registered
27/05/2016

Titles & IDs
Public title
Improving Pain Relief Following Laparoscopic Ventral Hernia Repair
Scientific title
Intra-abdominal Infusions of Ropivacaine Following Laparoscopic Ventral Hernia Repair: a Randomised Double-blind Controlled Trial.
Secondary ID [1] 0 0
COLVHR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Postoperative 0 0
Anesthesia, Local 0 0
Hernia, Ventral 0 0
Laparoscopy 0 0
Analgesics, Opioid 0 0
Complications 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - AutoFuser Pain Pump
Treatment: Drugs - Ropivacaine
Other interventions - Normal Saline (0.9%)

Experimental: Ropivacaine infusion - Following the insertion of the 2mm fenestrated catheter, the wound catheter will be connected to the 270mL AutoFuser Pain Pump. The intraperitoneal infusion with ropivacaine (0.2%) at 4 mL/hour will start immediately and continue for 68 hours post-operatively uninterrupted.

Placebo comparator: Placebo infusion - In the same manner as described for the ropivacaine infusion arm, 0.9% Normal Saline will be administered over 68 hours.


Treatment: Devices: AutoFuser Pain Pump
Closed loop local anaesthetic infusion system

Treatment: Drugs: Ropivacaine
Commonly used local anaesthetic drug

Other interventions: Normal Saline (0.9%)
Normal saline is a sterile, non-pyrogenic solution for fluid and electrolyte replenishment for intravenous administration. This will be the solution used for the intraperitoneal infusion in the placebo/control group.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Morphine equivalent use
Timepoint [1] 0 0
Total opiate consumption in the first 24 hours
Secondary outcome [1] 0 0
Post-operative pain scores
Timepoint [1] 0 0
Until day 7 post-operatively

Eligibility
Key inclusion criteria
* All consecutive consenting adult patients (=16 years) undergoing elective LVHR (umbilical / incisional / spigelian) will be screened for inclusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* acute presentation, open repair of ventral hernia, hepatic dysfunction ALT/AST = 2 x ULN, previous adverse reaction/allergy to ropivacaine, opiate use greater than 6 months, patients with a diagnosis of Chronic Pain Syndrome (CPS), patients under 16 years of age, patient refusal and those without the ability to consent

Study design
Purpose of the study
Other
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
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/08/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2018
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Andrew G Hill, MD, EdD, FACS, FRACS
Address 0 0
The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02785276