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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02785276
Ethics application status
Date submitted
23/05/2016
Date registered
27/05/2016
Date last updated
2/06/2016

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 - Total opiate analgesia (all routes) used from immediately post-operative (0h) during the post-operative recovery period up to 24 hours will be recorded and converted into morphine equivalents.
Timepoint [1] 0 0
Total opiate consumption in the first 24 hours
Secondary outcome [1] 0 0
Post-operative pain scores - Abdominal pain at rest, on moving (recumbent to the upright position), and on coughing will be assessed using 3 separate 10 point Visual Analogue Scales (VAS) preoperatively (baseline), at 2, 4, 6, 8, 12, 24, 48 and 72 hours as well as on day 7 postoperatively
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
Gender
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
Health Services Research
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Aim

The general aim of this study is to improve post-operative pain and reduce morphine
consumption following laparoscopic ventral hernia repair (LVHR). We specifically aim to
conduct a randomized, double blinded, controlled trial to investigate the effect of
intra-peritoneal local anaesthesia infusions on post-operative morphine consumption and.

Methods:

Patients will be randomised by computer generated random numbers (random permutation) and
opaque envelope methods. At closure, one small 2mm catheter belonging to the AutoFuser pain
pump system will be placed in the peritoneal cavity between the onlay mesh and parietal
peritoneum. In the treatment arm patients will receive 275mL of 0.2% ropivacaine at 4mL/h. In
the placebo arm, 275mL of 0.9% normal saline will be used in a similar fashion. The infusions
will run for 68 hours total. All members involved in patient care (with the exception of one
independant research fellow) will be blinded to the above. After 68 hours the pump will be
stopped and the catheter will be removed. Assessment of post-operative pain will be performed
by visual analogue scale, and total opiate consumption will be collected and converted into
morphine equivalents.

Health significance:

Local anaesthesia has become an important addition to multimodal regimens of analgesia
following surgery. Recent studies have shown that local anaesthetic (LA) wound infiltration
has improved post-operative pain when compared with standard opioid regimens for pain relief.
Only one previous study looked at bupivacaine infusions into the hernia sac for three days
following LVHR. This study found no improvement in post-operative pain or morphine
consumption. We aim to demonstrate improved pain and reduced morphine consumption using an
alternative catheter insertion technique and ropivacaine as the desired LA agent.
Trial website
https://clinicaltrials.gov/show/NCT02785276
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
Jamie-Lee Rahiri, MBChB
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
jrah004@aucklanduni.ac.nz
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02785276