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Trial registered on ANZCTR

Registration number

ACTRN12616000610437

Ethics application status

Approved

Date submitted

30/03/2016

Date registered

10/05/2016

Date last updated

21/04/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Optimal Duration of Adductor Canal Catheter Infusions for analgesia following Knee Arthroplasty

Scientific title

A prospective randomized controlled trial to compare 3 day vs 5 day adductor canal catheter infusions following knee arthroplasty

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

knee arthroplasty

post-operative pain

Condition category

Condition code

Anaesthesiology

Pain management

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Regional anaesthesia techniques provide far superior analgesia to opioid only analgesia following knee arthroplasty. Femoral nerve blocks have previously been considered the gold standard for analgesia however due to the effects on quadriceps strength these infusions have limited patients ability to mobilise and rehabilitate and have thus been of limited duration. Adductor canal block (ACB) infusions have provided equivalent analgesia to femoral nerve blocks while preserving motor strength and capacity to walk.
Intervention group will receive ACB Initial bolus = 30mls x 0.2% ropivacaine then continuous Infusion = 0.2% @ 6mls/h) for 5 days by an anaesthetist and monitored by an Acute Pain Service.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group will have standard care, which is only 3 days duration of ACB contuinuous low dose ropivacine infusion (Initial bolus = 30mls x 0.2% ropivacaine then continuous Infusion = 0.2% @ 6mls/h) for 3 days admisintered by an anaesthetist and monitored by an Acute Pain Service.

Control group

Active

Outcomes

Primary outcome [1]

Pain intensity when walking via numerical rating score 0-10

Timepoint [1]

Preop, Day 3-6, 3 Month post-op
Rated once each timepoint based on pain experienced in past 24 hours

Primary outcome [2]

Walking activity via accelerometer measuring % time active/ day

Timepoint [2]

Preop, Day3-6, 3 months post-op.
Activity monitor will be worn continuously for 7 days at preop baseline and 3 month
Outcome will be continuously worn from eve of post-operative Day 3 to morning of Day 6 to capture activity level each day.

Secondary outcome [1]

Hospital length of stay as calculated as the difference in whole days from the date the patient is admitted for surgery to the day they leave the hospital setting.

Timepoint [1]

Discharge day

Secondary outcome [2]

Recovery quality (QoR-15, Opioid Related Symptom Distress Scale) Modified to rate over last 48 hours

Timepoint [2]

Post-op Day 3 and 6

Secondary outcome [3]

Satisfaction with pain regime over the last 24 hours via numerical rating score 0-10

Timepoint [3]

At beginning each day, once on Days 3-6 Post-op

Eligibility

Key inclusion criteria

1. The individual has signed a Patient Informed Consent (PIC) specific to this study, and approved by the Institutional Ethics Review Board.
2. The individual clinically qualifies for elective unilateral primary or single-stage revision TKA surgery based on physical examination and medical history.
3. American Society Anaesthetists Score 1-3

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Previous major ipsilateral knee surgery.
2. Pre-existing neuropathy of the operative limb
3. Revision surgery for infection.
4. Allergy or sensitivity to local anaesthetics
5. The individual is a prisoner, physically or mentally compromised (i.e., currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse), and is unwilling or unable to comply with scheduled evaluations and/or rehabilitation.
6. Patients with comorbidities causing severe mobility impairment

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)

Following consent by th esurgeon, patient assignment to either 3 day or 5 day infusion was made by an independent researcher using a computer-generated sequence list

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

computer-generated randomisation list

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The study design to establish superiority of the 5 day duration, powered to detect a 15% difference in NRS. To achieve Power (1 - ß) = 0.80, a = .05 if there were a benefit of 1.5 to for the 5-day condition then data would be expected to liken to 3-day group ( M1 = 3, SD1 = 2) verses the 5-day group( M2 = 1.5, SD2 = 2) This would provide effect size (d) of .75 (where .80 is large).To detect this effect the recommended sample size is 29 per condition. This we aim to recruit 32 participants to each group, allowing for 10% attrition.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

6/06/2016

Actual

1/09/2016

Date of last participant enrolment

Anticipated

30/12/2016

Actual

21/02/2017

Date of last data collection

Anticipated

Actual

7/03/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Hollywood Private Hospital - Nedlands

Funding & Sponsors

Funding source category [1]

Other

Name [1]

The Joint Studio

Address [1]

1/ 85 Monash Ave
Nedlands WA 6009

Country [1]

Australia

Primary sponsor type

Other

Name

The Joint Studio

Address

1/ 85 Monash Ave
Nedlands WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hollywood Private Hospital HREC

Ethics committee address [1]

Hospital Ave, Nedlands WA 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/05/2016

Approval date [1]

07/07/2016

Ethics approval number [1]

Summary

Brief summary

There is a wide range of local analgesic techniques available for analgesia following total knee arthroplasty (TKA). In a recent review article, continuous femoral nerve block analgesia has been described as the ‘gold standard’.. A myriad of combinations of these techniques appear in the literature and all have some limitations.

Regional anaesthesia techniques provide far superior analgesia to opioid only analgesia following knee arthroplasty. Femoral nerve blocks have previously been considered the gold standard for analgesia however due to the effects on quadriceps strength these infusions have limited patients ability to mobilise and rehabilitate and have thus been of limited duration. Adductor canal block infusions have provided equivalent analgesia to femoral nerve blocks while preserving motor strength. Patients are able to walk independently while these infusions are running with limited pain. This is transforming post-operative care for these patients. 

We have audited 3 day infusions in this group of patients and found improvements in pain and mobility. We believe that prolonging the infusion duration may provide further benefits to patients.

The primary aim of this trial is to assess whether a 5 day ACB infusion is better than a 3 day infusion in terms of quality of analgesia and their walking activity level during the first week following their surgery. Our secondary aims are to evaluate safety of the technique and to ascertain if any benefits are carried over to the 3 month pain, walking level, hip function and satisfaction levels.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mark Lennon

Address

Anaesthetics Department
Hollywood Private Hospital
Monash Ave, Nedlands WA 6009

Country

Australia

Phone

+61 408230564

Fax

mjlennon007@gmail.com

Contact person for public queries

Name

Samantha Haebich

Address

The Joint Studio
1/ 85 Monash Ave Nedlands WA 6009

Country

Australia

Phone

+61 8 64609781

Fax

Research@thejointstudio.com.au

Contact person for scientific queries

Name

Scott Sargant

Address

Anesthetics Department
Hollywood Private Hospital
Monash Ave,Nedlands WA 6009

Country

Australia

Phone

61 8 9386 6000

Fax

scottsargant77@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
Study results article	Yes		Extended duration regional analgesia for total kne... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Extended Duration Regional Analgesia for Total Knee Arthroplasty: A Randomised Controlled Trial Comparing Five Days to Three Days of Continuous Adductor Canal Ropivacaine Infusion.	2018	https://dx.doi.org/10.1177/0310057X1804600311

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