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Trial registered on ANZCTR
Registration number
ACTRN12613000440729
Ethics application status
Approved
Date submitted
13/04/2013
Date registered
17/04/2013
Date last updated
25/02/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Intravenous lignocaine infusion for analgesia following laparoscopic hiatus hernia repair: A double-blinded, randomised, placebo-controlled trial.
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Scientific title
In adult patients undergoing laparoscopic hiatus hernia repair, how effective is intravenous lignocaine compared to placebo in controlling post operative pain.
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Secondary ID [1]
282330
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post operative pain following laparoscopic hiatus hernia repair
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Hiatus hernia
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Condition category
Condition code
Anaesthesiology
289218
289218
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0
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Pain management
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patients will be randomised to receive lignocaine or placebo, to begin following the induction of anaesthesia. The treatment regimen is as follows:
1. Loading dose (lignocaine or placebo): 1mg/kg (0.1ml/kg) administered intravenously as a single dose at a rate of 20mg/minute (2ml/minute). Following completion of the loading dose, immediate commencement of;
2. Constant rate infusion (lignocaine or placebo): 2mg/kg/hr (0.2ml/kg/hr) for 24 hours.
Dose titration / adjustment will not be performed. If adverse effects are seen, the infusion will be ceased. At the end of the treatment period, the study drug will be discontinued without tapering.
Each participant's involvement in the trial will end when they are discharged from hospital.
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Intervention code [1]
286945
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Treatment: Drugs
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Comparator / control treatment
The placebo formulation for this study is contained within a 500ml fluid bag that appears identical to the lignocaine study drug, though is composed only of 0.9% (w/v) sodium chloride.
Both intervention and control groups will receive (additional)analgesia consistent with the current standard of care.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Primary Hypothesis 1: Lignocaine-treated subjects will report clinically significant reductions in their post-operative pain (greater than 20mm decrease in visual analogue pain scores) at rest, compared with subjects given placebo over the 24 hour treatment period.
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Assessment method [1]
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Timepoint [1]
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VAS pain scores will be assessed during pre-anaesthetic examination, then 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36 hours following commencement of trial drug infusion.
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Primary outcome [2]
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Primary Hypothesis 2: Lignocaine-treated subjects will report clinically significant reductions in their post-operative pain (greater than 20mm decrease in visual analogue pain scores) during mobilisation, compared with subjects given placebo over the 24 hour treatment period.
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Assessment method [2]
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Timepoint [2]
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VAS pain scores will be assessed during pre-anaesthetic examination, then 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36 hours following commencement of trial drug infusion.
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Primary outcome [3]
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Primary Hypothesis 3: Lignocaine-treated subjects will report clinically significant reductions in their post-operative pain (greater than 20mm decrease in visual analogue pain scores) during coughing, compared with subjects given placebo over the 24 hour treatment period.
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Assessment method [3]
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Timepoint [3]
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VAS pain scores will be assessed during pre-anaesthetic examination, then 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36 hours following commencement of trial drug infusion.
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Secondary outcome [1]
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Secondary Hypothesis 1: Lignocaine-treated subjects will show a significantly greater reduction in nausea scores compared with subjects given placebo.
Participants will be asked to score their level of nausea using a visual analogue scale. Vomiting will be regarded as a maximum score of “10”.
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Assessment method [1]
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Timepoint [1]
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VAS nausea scores will be assessed during pre-anaesthetic examination, then 2, 4, 8, 12, 16, 20, 24, 28, 32 and 36 hours following commencement of trial drug infusion.
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Secondary outcome [2]
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Secondary Hypothesis 2: Lignocaine-treated subjects will show no difference or a reduction in hospital stay compared with subjects given placebo.
Length of hospital stay will be recorded in hours, and duration of hospitalisation will be compared between treatment and control groups.
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Assessment method [2]
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Timepoint [2]
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Discharge from hospital.
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Secondary outcome [3]
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Secondary Hypothesis 3: Lignocaine-treated subjects will show a significantly greater reduction in rescue analgesia compared with subjects given placebo.
Oral oxycodone will be provided as "rescue analgesia" for patients experiencing breakthrough pain. Consumption of oxycodone will be monitored for the duration of hospitalisation.
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Assessment method [3]
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Timepoint [3]
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Total consuption of oxycodone (reported in mg) will be summated when the participant is discharged from hospital.
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Secondary outcome [4]
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Secondary Hypothesis 4: Lignocaine-treated subjects will show the same rate of adverse events compared with subjects given placebo.
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study.
Nursing staff experienced in post-surgical care will monitor patients for adverse events. Frequency of AE will be compared between treatment and control groups.
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Assessment method [4]
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Timepoint [4]
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Assessed until discharge from hospital.
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Secondary outcome [5]
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Secondary Hypothesis 5: Lignocaine-treated subjects will not reach lignocaine plasma concentrations of > 5mcg/mL at the dose tested.
Lignocaine assay will be performed on plasma samples by the hospital pathology department.
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Assessment method [5]
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Timepoint [5]
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Samples will be collected and analysed from each participant at 0, 2, 4, 8, 12, 16, 20, 24, and 28 hours following commencement of trial drug infusion.
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Secondary outcome [6]
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Secondary Hypothesis 6: Lignocaine-treated subjects will show a significant reduction in pro-inflammatory cytokines compared with subjects given placebo.
The Luminex (Registered Trademark)-based Invitrogen (Trademark) Human Cytokine 30-Plex Panel provides quantitation of human immunological biomarkers including: IL-1RA, FGF-Basic, MCP-1, G-CSF, IFN-?, IL-12, IL-13, IL-7, VEGF, MIG, RANTES, Eotaxin, MIP-1ß, IP-10, IL-2R, IFN-a, IL-15, GM-CSF, TNF-a, IL-1ß, IL-2, IL-4, IL-5, IL-6, IL-10, MIP-1a, IL-17, IL-8, EGF, HGF.
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Assessment method [6]
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Timepoint [6]
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Blood samples will be collected from each participant at 0, 2, 4, 8, 12, 16, 20, 24, and 28 hours following commencement of trial drug infusion. The frequency of analyses performed will be known once project funds are secured.
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Eligibility
Key inclusion criteria
1. Male or female, aged 18 years or over;
2. Undergoing laparoscopic surgical repair of hiatus hernia by Prof Gregory Falk.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Known allergies to local anaesthetics;
2. Chronic use of analgesics or corticosteroids;
3. Impaired hepatic function;
4. Epilepsy or other seizure disorder;
5. Severe cardiac failure or cardiac arrhythmias (e.g. supraventricular arrhythmias, Stokes-Adams syndrome, severe sinoatrial, atrioventricular or intraventicular block);
6. Pregnancy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety
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Statistical methods / analysis
A sample size of 18 patients in each group has been calculated to be sufficient to detect a difference of 20mm in the mean VAS score for pain, assuming a standard deviation (SD) of 20mm, with a significance level a = 0.05 and a power of 0.90. A difference of 20mm in pain score was chosen as this was found to be the amount needed to cause a clinically significant reduction in a person’s experience of pain. 25 patients per group will be enrolled to compensate for possible dropouts.
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Date of first participant enrolment
Anticipated
3/05/2013
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Actual
31/05/2013
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Date of last participant enrolment
Anticipated
31/12/2014
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Actual
23/12/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Sydney Adventist Hospital - Wahroonga
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Dr Stephanie Phillips
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Address [1]
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Sydney Adventist Hospital Clinical School
185 Fox Valley Rd
Wahroonga NSW 2076
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr Stephanie Phillips
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Address
Sydney Adventist Hospital Clinical School
185 Fox Valley Rd
Wahroonga NSW 2076
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Country
Australia
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Secondary sponsor category [1]
285863
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None
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Name [1]
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N/A
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Address [1]
285863
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N/A
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Country [1]
285863
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289104
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Adventist HealthCare Limited Human Research Ethics Committee
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Ethics committee address [1]
289104
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Research Governance & Ethics Officer
Adventist HealthCare Limited
185 Fox Valley Road
WAHROONGA NSW 2076
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Ethics committee country [1]
289104
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Australia
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Date submitted for ethics approval [1]
289104
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Approval date [1]
289104
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02/04/2013
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Ethics approval number [1]
289104
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EC00141
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Summary
Brief summary
Despite the best efforts of medical practitioners, a short period of severe post-operative pain is still experienced by many patients undergoing surgery. This is particularly so in patients that undergo laparoscopic repair of a hiatus hernia, since there are limited pain relief options that do not cause nausea and vomiting (as these could ultimately lead to disruption of the surgical repair).
Many studies have shown that intravenous lignocaine infusion in the perioperative period is safe and has clear advantages in patients undergoing abdominal surgery. These same studies concluded that further research is needed to determine the optimum dose, timing and duration of infusion of lignocaine in this setting.
This study aims to evaluate the benefits and validate the safety of intravenous lignocaine for pain relief for patients undergoing laparoscopic repair of hiatus hernia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Stephanie Phillips
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Address
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Northern Specialist Anaesthetists
406A San Clinic
185 Fox Valley Road, Wahroonga
NSW 2076 AUSTRALIA
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Country
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Australia
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Phone
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+61 2 9473 8960
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mr Gregory Dale
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Address
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Sydney Adventist Hospital Clinical School
185 Fox Valley Road, Wahroonga
NSW 2076 AUSTRALIA
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Country
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Australia
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Phone
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+61 4 17288501
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mr Gregory Dale
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Address
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Sydney Adventist Hospital Clinical School
185 Fox Valley Road, Wahroonga
NSW 2076 AUSTRALIA
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Country
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Australia
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Phone
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+61 4 17288501
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Fax
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
The analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: A prospective, randomized, double-blind, placebo-controlled trial.
2016
https://dx.doi.org/10.2147/LRA.S119483
N.B. These documents automatically identified may not have been verified by the study sponsor.
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