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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.
Scientific title
In adult patients undergoing laparoscopic hiatus hernia repair, how effective is intravenous lignocaine compared to placebo in controlling post operative pain.
Secondary ID [1] 282330 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative pain following laparoscopic hiatus hernia repair 288877 0
Hiatus hernia 288890 0
Condition category
Condition code
Anaesthesiology 289218 289218 0 0
Pain management

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286945 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 289330 0
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.
Timepoint [1] 289330 0
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.
Primary outcome [2] 289331 0
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.
Timepoint [2] 289331 0
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.
Primary outcome [3] 289332 0
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.
Timepoint [3] 289332 0
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.
Secondary outcome [1] 302250 0
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”.
Timepoint [1] 302250 0
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.
Secondary outcome [2] 302251 0
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.
Timepoint [2] 302251 0
Discharge from hospital.
Secondary outcome [3] 302252 0
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.
Timepoint [3] 302252 0
Total consuption of oxycodone (reported in mg) will be summated when the participant is discharged from hospital.
Secondary outcome [4] 302253 0
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.
Timepoint [4] 302253 0
Assessed until discharge from hospital.
Secondary outcome [5] 302254 0
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.
Timepoint [5] 302254 0
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.
Secondary outcome [6] 302255 0
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.
Timepoint [6] 302255 0
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.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
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
Safety
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.

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
3/05/2013
Actual
31/05/2013
Date of last participant enrolment
Anticipated
31/12/2014
Actual
23/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 890 0
Sydney Adventist Hospital - Wahroonga

Funding & Sponsors
Funding source category [1] 287087 0
Self funded/Unfunded
Name [1] 287087 0
Dr Stephanie Phillips
Country [1] 287087 0
Australia
Primary sponsor type
Individual
Name
Dr Stephanie Phillips
Address
Sydney Adventist Hospital Clinical School
185 Fox Valley Rd
Wahroonga NSW 2076
Country
Australia
Secondary sponsor category [1] 285863 0
None
Name [1] 285863 0
N/A
Address [1] 285863 0
N/A
Country [1] 285863 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289104 0
Adventist HealthCare Limited Human Research Ethics Committee
Ethics committee address [1] 289104 0
Research Governance & Ethics Officer
Adventist HealthCare Limited
185 Fox Valley Road
WAHROONGA NSW 2076
Ethics committee country [1] 289104 0
Australia
Date submitted for ethics approval [1] 289104 0
Approval date [1] 289104 0
02/04/2013
Ethics approval number [1] 289104 0
EC00141

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39154 0
Dr Stephanie Phillips
Address 39154 0
Northern Specialist Anaesthetists
406A San Clinic
185 Fox Valley Road, Wahroonga
NSW 2076 AUSTRALIA
Country 39154 0
Australia
Phone 39154 0
+61 2 9473 8960
Fax 39154 0
Email 39154 0
[email protected]
Contact person for public queries
Name 39155 0
Gregory Dale
Address 39155 0
Sydney Adventist Hospital Clinical School
185 Fox Valley Road, Wahroonga
NSW 2076 AUSTRALIA
Country 39155 0
Australia
Phone 39155 0
+61 4 17288501
Fax 39155 0
Email 39155 0
[email protected]
Contact person for scientific queries
Name 39156 0
Gregory Dale
Address 39156 0
Sydney Adventist Hospital Clinical School
185 Fox Valley Road, Wahroonga
NSW 2076 AUSTRALIA
Country 39156 0
Australia
Phone 39156 0
+61 4 17288501
Fax 39156 0
Email 39156 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseThe analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: A prospective, randomized, double-blind, placebo-controlled trial.2016https://dx.doi.org/10.2147/LRA.S119483
N.B. These documents automatically identified may not have been verified by the study sponsor.