Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000221156
Ethics application status
Approved
Date submitted
6/02/2019
Date registered
14/02/2019
Date last updated
21/02/2020
Date data sharing statement initially provided
14/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising pain relief after knee joint replacement surgery at Counties Manukau Health; We compare two methods of local anaesthesia (numbing medicine) administration to reduce pain after knee replacement surgery.
Scientific title
Comparison of continuous infusion against programmed intermittent bolus of local anaesthesia through adductor canal catheter after total knee arthroplasty.
Secondary ID [1] 297310 0
Nil known
Universal Trial Number (UTN)
U1111-1225-6348
Trial acronym
DETACH-TKA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief after Total Knee Arthroplasty
 311413 0
Condition category
Condition code
Anaesthesiology 310039 310039 0 0
Pain management
Surgery 310113 310113 0 0
Other surgery
Musculoskeletal 310114 310114 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing Total Knee Arthroplasty will be randomly assigned to one of two groups in a double-blinded manner. They will all receive the established pain relief treatment (Adductor Canal Catheter - a peripheral nerve catheter) and have 0.2% ropivacaine as the local anaesthetic.

1. Group 1 - Continuous infusion of local anaesthesia at 5mls/hr of 0.2% ropivacaine (10mg/hr)
2. Group 2 - Programmed intermittent bolus of local anaesthesia - 10mls every 2 hours of 0.2% ropivacaine. (20mg every 2 hours)

The infusion will start in the postoperative anaesthetic care unit (PACU) and continue for 48 hours after the start of the study drug/method of delivery.

We will follow up at least once daily for 72 hours after commencing study infusion, we will check adherence to study protocol and document any violations or deviation from prescribed methods; audit of hospital records, medication charts and participant's responses will be used to monitor adherence to study protocol.
Intervention code [1] 313561 0
Treatment: Drugs
Comparator / control treatment
we will compare between
1) Active group - programmed intermittent bolus of 0.2% ropivacaine (10mls every 2hrs)
2) Comparator group - continuous infusion of 0.2% ropivacaine (5mls / hr)
Control group
Active

Outcomes
Primary outcome [1] 318939 0
Total oral morphine consumption over 48 hours after starting study infusion in PACU. Conversion to daily oral morphine equivalence will be calculated based on the methods prescribed by the Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists

We will gather this information from paper-based and electronic hospital records.
Timepoint [1] 318939 0
24, 48 hours after commencement of infusion in post-operative anaesthetic care unit (PACU)

The primary outcome measured at 48 hours after commencing infusion in PACU.
Secondary outcome [1] 366471 0
Quality of Recovery (QoL-15) scores
Timepoint [1] 366471 0
24, 48, 72 hours (if not discharged) after study infusion commencement
Secondary outcome [2] 366472 0
Timed Up and Go (TUG) test.
- time taken (in seconds) to stand up from chair, walk 3 meters, turn around and sit down again.
Timepoint [2] 366472 0
24, 48, 72 hours after study commencement in PACU
Secondary outcome [3] 366473 0
Passive range of movement of the knee using a goniometer
Timepoint [3] 366473 0
24, 48, 72 hours (if not discharged) after the operation
Secondary outcome [4] 366474 0
Time (in minutes) to the first mobilization after discharge from PACU.
Timepoint [4] 366474 0
measured in minutes from commencement of study in PACU.

This data will be gathered from Physio or Nursing staff report and hospital notes.
Secondary outcome [5] 366475 0
Hospital length of stay measured in days
Timepoint [5] 366475 0
follow up patients daily until discharged.

We will determine day of discharge from hospital records / completion of a discharge summary.
Secondary outcome [6] 366476 0
Number of antiemetic doses required
Timepoint [6] 366476 0
over 48 hour study period.

This will be assessed from the collection of data from the medication chart as well as those reported/questionnaire completed by the participants.
Secondary outcome [7] 366478 0
Side effects from opioid consumption- Nausea & Vomiting
Timepoint [7] 366478 0
24, 48, 72 hours.

Collected from participant interview / questionaire as well as use of antiemetics in the medication charts / hospital records
Secondary outcome [8] 366705 0
Side effects - opioid-induced sedation.
Timepoint [8] 366705 0
24, 48, 72 hours.

data collected from participant questionnaire QoR-15 (quality of Recovery 15 questionnaire) / Participant verbal report / patient hospital records. calculation of pasero opioid induced sedation scale if relevant.
Secondary outcome [9] 366793 0
Pruritis
Timepoint [9] 366793 0
24, 48, 72 hours after commencement of infusion in PACU. we will measure using a verbal rating scale for this study (0-4, none-mild-moderate-severe itch)

Eligibility
Key inclusion criteria
We aim to enrol patients undergoing primary TKA in our institution prior to the day of surgery in the preadmission clinic or on the day of surgery at the time of surgical and anaesthetic consent. Adequate time for patient questions and a plain language explanation sheet will be provided to aid patient consent. The study will be completed at Middlemore Hospital and Manukau Surgical Centre.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
•Refusal or inability to consent.
•Analgesic technique involving epidural or peripheral nerve blockade (single shot or continuous techniques)
•Nerve catheter placed outside accepted range (distal to femoral triangle down to the adductor canal)
•Allergies to medication used in the study or its constituents
•Significant kidney and liver dysfunction (CrCl < 30mls/min, AST/ALT >2x upper limit of normal)
•Surgical procedure performed outside of Counties Manukau Health facilities.
•Failure to site adductor canal catheter in the appropriate location.
•Patients on >30mg/day of oral morphine equivalent for any reason.
•Patients outside the specified age range of 18-80 years.
•Patients at extremes of weight e.g.<50kg or >150kg
•If surgical team do not wish to take part or give individually tailored treatment that violate study protocol.

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)
Participants will be randomly allocated using opaque envelopes to one of the two groups outlined earlier.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation process - we will have equal numbers of opaque envelopes with group A vs Group B and this will be drawn randomly in the PACU and participant will be assigned to their respective group.
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 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical assessment of trial data will be devised and performed by a biostatistician. Patient demographic, surgical and anaesthetic factors will be recorded and tabulated. Demographic data will be presented as number (percentage) for discrete observation and mean (standard deviation) for continuous parameters.

For primary outcome (analgesic consumption in oral morphine equivalents) a test for differences in means / variances will be performed as guided by the data. Statistical test will be two-tailed with p=0.05 used as the threshold for statistical significance. Where possible, the clinical relevance of a statistical test will be provided in addition to the p-value. Similar testing strategies will be used for the secondary outcomes with differences in discrete observations (e.g. yes/no data) determined using the Fisher Exact test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
1/05/2019
Date of last participant enrolment
Anticipated
1/03/2020
Actual
Date of last data collection
Anticipated
28/03/2020
Actual
Sample size
Target
72
Accrual to date
66
Final
Recruitment outside Australia
Country [1] 21252 0
New Zealand
State/province [1] 21252 0
Counties Manukau Health facilities, Auckland, New Zealand

Funding & Sponsors
Funding source category [1] 301873 0
Hospital
Name [1] 301873 0
Counties Manukau Health - Middlemore Hospital Research Office
Country [1] 301873 0
New Zealand
Primary sponsor type
Hospital
Name
Counties Manukau Health, Middlemore Hospital Research Office
Address
Research Office
Middlemore Hospital, Private Bag 93311, Otahuhu, Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 301623 0
None
Name [1] 301623 0
Address [1] 301623 0
Country [1] 301623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302565 0
Health and Disability Ethics Comittees (NZ) HDEC
Ethics committee address [1] 302565 0
Ethics committee country [1] 302565 0
New Zealand
Date submitted for ethics approval [1] 302565 0
16/01/2019
Approval date [1] 302565 0
29/01/2019
Ethics approval number [1] 302565 0
19/NTA/9

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90674 0
Dr David Choi
Address 90674 0
Department of Anaesthesia and Pain Medicine,

Middlemore Hospital, Private Bag 93311, Otahuhu, Auckland 1640
Country 90674 0
New Zealand
Phone 90674 0
+64 9 276 0000 (via operator)
Fax 90674 0
Email 90674 0
[email protected]
Contact person for public queries
Name 90675 0
David Choi
Address 90675 0
Department of Anaesthesia and Pain Medicine,

Middlemore Hospital, Private Bag 93311, Otahuhu, Auckland 1640
Country 90675 0
New Zealand
Phone 90675 0
+64 9 276 0000 (via operator)
Fax 90675 0
Email 90675 0
[email protected]
Contact person for scientific queries
Name 90676 0
David Choi
Address 90676 0
Department of Anaesthesia and Pain Medicine,

Middlemore Hospital, Private Bag 93311, Otahuhu, Auckland 1640
Country 90676 0
New Zealand
Phone 90676 0
+64 9 276 0000 (via operator)
Fax 90676 0
Email 90676 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We did not seek ethics approval for sharing confidential participant data to the public - HDEC ethics committee have approved our study with the understanding that we keep our data on a password protected file on our local internal server.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.