ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000123246

Ethics application status

Approved

Date submitted

24/11/2017

Date registered

29/01/2018

Date last updated

30/01/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Intravenous lidocaine in the prevention of postoperative ileus

Scientific title

A randomised double blind placebo controlled trial of intravenous lidocaine to reduce the duration of postoperative ileus in patients undergoing elective colorectal surgery

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1198-4332

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Post operative ileus

Condition category

Condition code

Surgery

Other surgery

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients in the intervention group undergoing colorectal surgery will be administered intravenous lidocaine. The dose of lidocaine will be 2mg/kg bolus at induction of anaesthesia with a 2mg/kg/hr infusion to a maximum of 150mg/hr, the infusion will continue until 2 hours post op

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

Patients in the control group will receive a placebo in the form of normal saline 0.9% via intravenous administration

Control group

Placebo

Outcomes

Primary outcome [1]

Duration of post operative ileus
- this is a composite outcome measured by time till tolerating solid food and time till passage of stool - assessed by nursing staff on ward as part of Enhanced Recovery After Surgery (ERAS) protocol, or by self reporting by participants if discharged from hospital prior to achieving these outcomes

Timepoint [1]

Measurements will be taken twice daily until outcome is achieved.
Maximum follow-up will be 7 days post discharge from hospital

Secondary outcome [1]

Post operative pain as measured by composite measures of visual analogue scale and morphine equivalent dose

Timepoint [1]

Measured twice daily until date of discharge

Secondary outcome [2]

Time until discharge from hospital

Timepoint [2]

Will be assessed twice daily until time of discharge

Secondary outcome [3]

Complication rates
For example
Operative complications - wound infection, anastomotic leak, post operative haemorrhage, As diagnosed by the treating team
Other non-operative complications - Cardiovascular complications (myocardial infarct, arrhythmia), respiratory complications (pneumonia), neurological complications (seizure) will be diagnosed by the treating team,

Timepoint [3]

All post operative complications will be recorded until 30 days post operatively

Secondary outcome [4]

Systemic inflammation marker levels - CRP and WCC

Timepoint [4]

These blood markers of inflammation will be recorded as per usual care until the time of discharge. Usual care would be for daily blood testing until the date of discharge

Eligibility

Key inclusion criteria

All patients undergoing elective colorectal surgery
Able to give informed consent

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Allergy to lidocaine
• ASA 4 or greater
• Active inflammatory bowel disease
• Moderate to severe renal impairment (Creatinine clearance <50ml/min/1.73m2)
• Severe hepatic impairment (Child-Pugh C)
• Moderate to severe congestive cardiac failure (NHYA 3 or 4)
• Pregnancy
• Pre-existing gut dysmotility disorder including endocrine, metabolic or neurological cause
• Pre-operative malnutrition requiring parenteral nutrition
• Inability to give consent or participate in post-operative assessments
• Primary, secondary or tertiary heart block
• Shock
• Drugs known to reduce lidocaine metabolism e.g. cimetidine

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Yes - central randomisation

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

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

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Previously unpublished data obtained as part of a prospective trial on post-operative ileus at Auckland City Hospital, was provided to us by colleagues at Auckland City Hospital. Data was extracted from 93 patients undergoing elective bowel resection without ileostomy formation, forming the basis of our power calculations. Retrospective data showed mean time to both tolerance of a solid diet and passage of stool = 4.9 days (SD = 2.6 days). This calculation has been performed with the assistance of a statistician. Assumptions were a= 0.05, ß= 0.2, Power= 80% and for a two-tailed test. Allocation ratio was 1:1. The study is designed to find a difference between 2 independent means.
To detect a clinically relevant reduction of 36 hours (25%) in the time to tolerate food and pass stool (from 4.9 days to 3.6 days) n= 64 patients required per group, therefore a total of 128 patients will need to be recruited for this study. We will aim to recruit 140 patients in order to account for any dropout.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/02/2018

Actual

Date of last participant enrolment

Anticipated

28/09/2018

Actual

Date of last data collection

Anticipated

5/10/2018

Actual

Sample size

Target

140

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Departments of Surgery and Anaesthesia, Christchurch Hospital

Address [1]

2 Riccarton Ave
Christchurch 8011

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago, Christchurch

Address

2 Riccarton Ave
Christchurch 8011

Country

New Zealand

Secondary sponsor category [1]

Hospital

Name [1]

Christchurch Hospital

Address [1]

2 Riccarton Ave
Christchurch 8011

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
133 Molesworth St
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

16/08/2017

Approval date [1]

09/11/2017

Ethics approval number [1]

17/NTA/180

Summary

Brief summary

Postoperative ileus (POI) is a common sequelae of abdominal surgery and is characterised by a period of gastrointestinal dysmotility. Common symptoms include nausea, vomiting, inability to tolerate oral diet and inability to pass flatus or stool. Patients with POI commonly have abdominal distension, they may require nasogastric tube (NGT) insertion to relieve gastric distension. POI interferes with patient mobility post operatively and evidence suggests that more than 50% of patients who develop POI will also develop further complications, significantly increasing their postoperative length of stay and mortality.
POI is a common condition, a recent series at Auckland City Hospital identified 26.9% of patients as having prolonged postoperative ileus. This is an issue which places a significant burden on healthcare resources and spending; a recent study estimates an annual economic burden of over $1.4 billion in the United States alone.
The exact mechanism of POI is unclear, however important factors in its development include use of pharmacological agents (particularly opiates), neural mechanisms, and intestinal inflammation. Anti-inflammatory drugs such as COX-2 inhibitors have shown some effect in animal and human models in preventing and reducing the duration of POI.
Lidocaine is a local anaesthetic medication. Similar local anaesthetic medications are routinely used in elective surgery for analgesia via epidural or local infiltration. There is evidence that epidural local anaesthetic is effective in the prevention of POI. It has recently been suggested that the clinical effect is due to systemic absorption of the local anaesthetic, studies have shown that intravenously administered local anaesthetic is effective at reducing rates of POI. The mechanism of action may be due to reduced opiate consumption post operatively due to the analgesic effect of lidocaine, however studies have shown a significant attenuation of the post-surgical inflammatory response following administration of parenteral lidocaine, and this may also contribute to its’ effect.
This study aims to assess the duration of POI following the administration of parenteral lidocaine intraoperatively and up to 2 hours post operatively, compared to placebo. Primary end points will include, time to resolution of POI as defined by established criteria. Secondary end points will include pain scores, markers of systemic inflammation, complication rates and length of hospital stay.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michael Russell

Address

Dept of General Surgery
Christchurch Hospital
2 Riccarton Ave
Christchurch 8011

Country

New Zealand

Phone

+64221572420

Fax

mike.russell@outlook.com

Contact person for public queries

Name

Michael Russell

Address

Dept of General Surgery
Christchurch Hospital
2 Riccarton Ave
Christchurch 8011

Country

New Zealand

Phone

+64 3-364 0640

Fax

mike.russell@outlook.com

Contact person for scientific queries

Name

Michael Russell

Address

Dept of General Surgery
Christchurch Hospital
2 Riccarton Ave
Christchurch 8011

Country

New Zealand

Phone

+64 3-364 0640

Fax

mike.russell@outlook.com

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

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