ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000129280

Ethics application status

Approved

Date submitted

22/11/2017

Date registered

30/01/2018

Date last updated

30/01/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

In patients receiving regional anaesthesia of the arm for arteriovenous(AV) fistula surgery, can washout with normal saline increase the speed of resolution of the block after the surgery has been completed.

Scientific title

Reversing the effects of peripheral nerve block in patients undergoing AV fistula surgery using normal saline to "wash off" the block with 10mL of saline every 15 minutes following the surgery speed the offset of the block in terms of return of motor and sensory function.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Regional anaesthesia

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Following completion of AV fistula surgery the patient is transferred to the recovery room. Here a recovery nurse will flush 10ml of normal saline down the peripheral nerve catheter every 15 minutes for one hour, in the intervention group, and the control group has nothing done to the catheter. A blinded observer then assesses the patients block, 4 times during the hour that the patient stays in recovery. They assess the motor and sensory function in the 4 major nerves of the arm, and assess the pain scores of the patient.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group has a peripheral nerve catheter, but no washout.

Control group

Active

Outcomes

Primary outcome [1]

Motor function is assessed with movements controlled by the 4 major nerves and graded on Bromage score of 0 to 5 depending on the strength of the movement.

Timepoint [1]

There are 4 assessments of the patients block during their time in recovery. These are timed to be 5 minutes after the intervention (normal saline flush), in the intervention group and at the same time in the control group. This means the block is assessed when the patient first reaches recovery and then every 15 minutes for one hour.

Primary outcome [2]

Sensory function of the forearm in terms of light touch and temperature sensation in the 4 nerve territories of the arm.

Timepoint [2]

Every 15 minutes for 1 hour.

Primary outcome [3]

Pain scores self reported by the patient on scale of 1-10.

Timepoint [3]

Every 15 minutes for one hour.

Secondary outcome [1]

None

Timepoint [1]

None

Eligibility

Key inclusion criteria

• Provide informed written consent
• Adult (18 years or older) patients
• Having AV fistula formation under brachial plexus block
The patients block is measured on first admission to recovery room, and then every 15 minutes for one hour while in the recovery room. AV fistula patients are routinely discharged home after one hour in recovery.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Failure to provide informed consent
• Infection at the needle insertion site
• Known coagulopathy
• Known allergy to local anesthetics
• Presence of sensory or motor impairment in the distribution of the brachial plexus prior to nerve blockade
• Inability to perform valid sensory or motor assessment due to impaired access to the limb, language barrier, or inability of the subject to co-operate with such examination

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)

20 patients will be allocated to each group, so 40 slips of paper containing the group allocation will be placed into envelopes that will be drawn randomly from a box when a patient is recruited into the study.

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

Randomly drawn envelope.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data will be recorded on a data sheet and transferred to an Excel spreadsheet for statistical analysis. Comparisons between groups will be performed with Student’s t-test. Qualitative data will be reported as either absolute numbers or percentage and will be analyzed by Chi-square analysis or Fisher’s exact test, whichever is appropriate. A p value of < 0.05 will be considered statistically significant.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

10/11/2014

Date of last participant enrolment

Anticipated

Actual

20/01/2016

Date of last data collection

Anticipated

Actual

20/01/2016

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Waikato

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Waikato hospital

Address [1]

Dept. of Anaesthesia
Waikato hospital
Pembroke Street
Hamilton 3200

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Waikato hospital

Address

Pembroke Street
Hamilton 3200

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Nil

Address [1]

Nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Ethics committee

Ethics committee address [1]

Health and Disability Ethics Committees
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

15/03/2014

Approval date [1]

01/05/2014

Ethics approval number [1]

14/NTB/45

Summary

Brief summary

Background and rationale
Peripheral nerve blocks provide effective surgical anesthesia targeted to specific body regions while avoiding the unpleasant side-effects of general anesthesia. 
There are occasions when rapid and effective block reversal is needed. For example, interscalene brachial plexus block for upper extremity surgery frequently causes paralysis of the diaphragm due to inadvertent anesthesia of the phrenic nerve. A method to ‘wash out’ the local anesthetic around the phrenic nerve in these cases would be beneficial,  Or in cases where patients are being discharged home the same day, and normal motor and sensory function of the limb in beneficial.
Several studies have demonstrated that epidural washout using normal saline (NS) or Ringer’s lactate following epidural block facilitates more rapid recovery of motor function and sensation than letting the block resolve on its own. However, no studies to date have addressed whether washout is effective for reversal of peripheral nerve blocks. A recently published report  suggests that a bolus of NS through a perineural catheter can rapidly and effectively restore phrenic nerve function following interscalene block.

Study objective
To demonstrate that infusion bolus of NS can be used in a clinical setting to modify the properties of a nerve block in patients who have received a nerve block for surgery and are expected to have minimal pain post operatively.

Hypothesis
We hypothesize that NS can be delivered through a perineural catheter to ‘wash out’ a nerve block to the point that function of the nerves returns. .

Trial website

Trial related presentations / publications

Smith C, Byrne K, Termaat J, Tsui B.  A simple method to reverse peripheral nerve blockade.  Poster presentation at the NZ Anaesthesia Annual Scientific Meeting, Rotorua, November 8-11, 2017.

Public notes

Contacts

Principal investigator

Name

Dr Kelly Byrne

Address

Dept. of Anaesthesia
Waikato hospital
Pembroke Street
Hamilton 3200
New Zealand

Country

New Zealand

Phone

+642102224390

Fax

kpa.byrne@gmail.com

Contact person for public queries

Name

Kelly Byrne

Address

Dept. of Anaesthesia
Waikato hospital
Pembroke Street
Hamilton 3200
New Zealand

Country

New Zealand

Phone

+642102224390

Fax

kpa.byrne@gmail.com

Contact person for scientific queries

Name

Kelly Byrne

Address

Dept. of Anaesthesia
Waikato hospital
Pembroke Street
Hamilton 3200
New Zealand

Country

New Zealand

Phone

+642102224390

Fax

kpa.byrne@gmail.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

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		No difference between the groups
Study results article	Yes		Reversing the Effects of a Peripheral Nerve Block ... [More Details]	374034-(Uploaded-15-05-2020-09-23-42)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Reversing the Effects of a Peripheral Nerve Block with Normal Saline: A Randomised Controlled Trial	2020	https://doi.org/10.5152/tjar.2019.09076

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically