Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000700134
Ethics application status
Approved
Date submitted
4/05/2019
Date registered
9/05/2019
Date last updated
9/05/2019
Date data sharing statement initially provided
9/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Efficacy of IntraOsseous Ropivacaine in Lower Extremity (SORE) Study
Scientific title
SORE Study - Safety and Efficacy of IntraOsseous Ropivacaine in Anterior Cruciate Ligament Reconstruction
Secondary ID [1] 298141 0
None
Universal Trial Number (UTN)
Trial acronym
SORE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament reconstruction 312680 0
Pain relief 312681 0
Condition category
Condition code
Musculoskeletal 311177 311177 0 0
Other muscular and skeletal disorders
Surgery 311178 311178 0 0
Surgical techniques
Anaesthesiology 311179 311179 0 0
Anaesthetics
Anaesthesiology 311180 311180 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of intervention: Intraosseous ropivacaine

Patients undergoing primary anterior cruciate ligament reconstruction will be randomly assigned to one of two intervention groups.

Group 1: 1.5 mg/kg ropivacaine
Group 2: 2.0 mg/kg ropivacaine

Study medications for each group will be made up to 140ml aliquots and will be prepared by trained medical staff prior to administration. A tourniquet will be inflated on the upper thigh before the study medication is delivered by the operating surgeon into bone via a proximal tibial cannula and immediately prior to skin incision.

There is no need to assess or monitor patient fidelity as they will be under the effect of general anaesthesia when they receive the intervention.
Intervention code [1] 314363 0
Treatment: Drugs
Comparator / control treatment
Control group: High volume local anaesthetic (bupivacaine) administered into the soft tissue around the knee at the end of surgery by the operating surgeon (standard of care).
Control group
Active

Outcomes
Primary outcome [1] 319947 0
Arterial blood concentration of ropivacaine
Timepoint [1] 319947 0
Blood samples will be taken 10 and 30 minutes after tourniquet inflation and drug administration (samples 1 and 2); then subsequently at 2 (sample 3), 5 (sample 4), 8 (sample 5), 12 (sample 6), 17 (sample 7), 25 (sample 8), 30 (sample 9), 45 (sample 10), 60 (sample 11) and 120 (sample 12) minutes after tourniquet deflation.
Secondary outcome [1] 369959 0
Pain - measured using the visual analogue scale (VAS; 0-100mm).
Timepoint [1] 369959 0
A baseline pain score using the visual analogue scale (VAS; 0-100mm) will be recorded pre-operatively.
Pain scores using the VAS will also be taken every 15 minutes after patient arrival on the recovery unit for 120 minutes.
Secondary outcome [2] 369963 0
Adverse effects including muscular rigidity, muscle twitching, unconsciousness, convulsions, hypoxia, apnoea, severe hypotension, arrhythmias and cardiac arrest.
Patients will be monitored for adverse effects by trained recovery nurses.
Timepoint [2] 369963 0
Patients will be returned to the recovery unit where continuous monitoring will continue for the duration of their recovery disposition (approx 90-120mins).
Secondary outcome [3] 370250 0
Total post-operative opioid consumption (mg)
Timepoint [3] 370250 0
Measures total consumption from arrival on recovery unit to patient discharge (recorded by trained nursing staff)

Eligibility
Key inclusion criteria
All patients undergoing anterior cruciate ligament (ACL) reconstruction would be eligible to participate in this prospective trial.
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sensitivity or known allergy to ropivacaine
Sensitivity or known allergy to intralipid
Significant cardiac history
Known epilepsy or history of seizures
Precluded from having general anaesthesia
Spinal anaesthesia or peripheral nerve block
Severe hepatic disease
Lower limbs not amenable to effective tourniquet use
Hypertension (Systolic BP > 180mmHg)

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation process - Upon gaining consent, a single envelope will be chosen and handed to the theatre staff to assist in preparation of the study medication ready for administration
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Means, standard deviations, and the 95% confidence limits will be calculated for the concentrations in the different samples. Repeated measure analysis of variance will be used to compare the average level of concentration across time between groups adjusted by BMI, age, and length of surgical procedure; Shapiro-Wilk test will be used to assess the normality of the residuals. Adverse events will be recorded by contingency table.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 21451 0
New Zealand
State/province [1] 21451 0
Auckland

Funding & Sponsors
Funding source category [1] 302677 0
Charities/Societies/Foundations
Name [1] 302677 0
Orthopaedic Education and Research Fund - Three Harbours Health Foundation
Country [1] 302677 0
New Zealand
Primary sponsor type
Individual
Name
Simon Young
Address
North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road
Westlake
0620
Auckland
Country
New Zealand
Secondary sponsor category [1] 302598 0
Individual
Name [1] 302598 0
Richard Rahardja
Address [1] 302598 0
University of Auckland
85 Park Road
Grafton
1023
Auckland
Country [1] 302598 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303290 0
Health and Disability Ethics Committee
Ethics committee address [1] 303290 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 303290 0
New Zealand
Date submitted for ethics approval [1] 303290 0
Approval date [1] 303290 0
09/04/2019
Ethics approval number [1] 303290 0

Summary
Brief summary
The aim of the study is to evaluate delivery of intraosseous (IO) regional ropivacaine in lower limb surgery (anterior cruciate ligament reconstruction) and, determine the safety (and efficacy) of two different doses in reducing perioperative pain.

Compared to high volume local anaesthesia (HVLA) or peripheral nerve blocks which can sometimes be incomplete and lack the necessary coverage of the extremity, a Bier’s block procedure of the lower limb is a reliable and predictable means for intraoperative analgesia during ACL reconstruction surgery.

The use of intraosseous ropivacaine with an inflated tourniquet may reduce intraoperative analgesia and result in prolonged immediate postoperative analgesia. During the time of tourniquet inflation, local anaesthesia disperses into the surrounding soft tissue (from IO to IV then subsequent soft tissue). Greater concentrations of anaesthesia achieved in the soft tissue at tourniquet deflation means longer times until complete clearance of the medication and therefore prolonged anaesthesia. This reduces the unexpected need for rescue analgesia including opioids whose side effect profile can impair patient recovery through nausea and vomiting, sedation, constipation and respiratory depression.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93150 0
Mr Simon Young
Address 93150 0
North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road
Westlake
0620
Auckland
Country 93150 0
New Zealand
Phone 93150 0
+64 9 486 8900
Fax 93150 0
Email 93150 0
simon.young@auckland.ac.nz
Contact person for public queries
Name 93151 0
Simon Young
Address 93151 0
North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road
Westlake
0620
Auckland
Country 93151 0
New Zealand
Phone 93151 0
+64 9 486 8900
Fax 93151 0
Email 93151 0
simon.young@auckland.ac.nz
Contact person for scientific queries
Name 93152 0
Simon Young
Address 93152 0
North Shore Hospital
Waitemata District Health Board
124 Shakespeare Road
Westlake
0620
Auckland
Country 93152 0
New Zealand
Phone 93152 0
+64 9 486 8900
Fax 93152 0
Email 93152 0
simon.young@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.