Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000969460p
Ethics application status
Not yet submitted
Date submitted
2/08/2025
Date registered
3/09/2025
Date last updated
3/09/2025
Date data sharing statement initially provided
3/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Arthroscopic administration of local anaesthesia in the posterior joint capsule after posteromedial meniscal repair and ACL reconstruction - a prospective randomised controlled trial
Scientific title
Effect of arthroscopic administration of local anaesthesia in the posterior joint capsule on initial and short-term pain after posteromedial meniscal repair and ACL reconstruction - a prospective randomised controlled trial
Secondary ID [1] 315052 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesiology 338412 0
Other muscular and skeletal disorders 338413 0
Pain management 338415 0
Condition category
Condition code
Anaesthesiology 334719 334719 0 0
Pain management
Musculoskeletal 334811 334811 0 0
Other muscular and skeletal disorders
Surgery 334812 334812 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intraoperative Injection of a weight-dependent dose of local anaesthaetics (LA) (ropivacaine, max 3mg/kg) into the posterior joint capsule of the knee in patients treated with an ACL reconstruction and posteromedial meniscal repair (intervention group). The weight-dependent doses used for the study, 0.75% ropivacaine: 1.5mg/kg for 60-80kg, 2.5mg/kg for 80-100kg, 3.0 mg/kg for >100kg body weight. The amount of LA will be administered after drilling the femoral ACL tunnels and before passing the ACL graft into the joint.
Intervention code [1] 331658 0
Treatment: Drugs
Intervention code [2] 331659 0
Treatment: Surgery
Comparator / control treatment
Control group (ACL reconstruction and posteromedial meniscal repair): no intraoperative injection of LA
Control group
Active

Outcomes
Primary outcome [1] 342374 0
Initial and short-term postoperative knee pain after reconstruction of the anterior cruciate ligament and posteromedial mensical repair after usage of an injection of LA in the posterior joint capsule will be assessed as an composite primary outcome.
Timepoint [1] 342374 0
Daily pain diary initial 2 weeks, and once after 6 and 12 weeks postoperatively
Secondary outcome [1] 450569 0
Consumption of pain peroral pain relief
Timepoint [1] 450569 0
Daily pain diary initial 2 weeks, and once at 6 and 12 weeks postoperatively
Secondary outcome [2] 450852 0
Analysis of complications (adverse events, revision surgery, ..). Potential adverse affects or complications are surgical site infection (deep/superficial), temporary damage to neurovascular structures or allergic reactions to LA.
Timepoint [2] 450852 0
Complications will be monitored throughout the duration of observation (up to 12 weeks postoperatively)

Eligibility
Key inclusion criteria
• Adults aged minimum 18 years with MRI-confirmed ACL rupture and medial meniscus tear (case and control cohort)
• Suitable candidates for ACLR (hamstrings, patellar tendon, peroneus longus, allograft) with posteromedial MR (all repair techniques, minimum of two sutures/anchors).
• Minimum body weight of 60 kg.
• Willingness to comply with follow-up visits and assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Irreparable ACL/meniscal injury or tear patterns for ACL repair.
• Concomitant need for repair of further ligaments/lateral meniscus of the affected knee.
• Age below 18 years.
• Previous surgeries to ipsilateral ACL/medial meniscus.
• Presence of pre-operative history of chronic pain issues or chronic consumption of pain relief.
• Infection.
• Pregnancy and lactation.
• A history of substance abuse, or current substance abuse problem
• Absence of Informed consent.

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Firstly, the mean (SD, range) of all subjective measures collected (pain scores) and oral analgesic requirements will be calculated, with groups compared over the post-operative collection period. Continuous outcomes will be analysed using mixed-effects models to account for repeated measures. The number (and type) of surgical complications, post-operative adverse events, re-injuries and/or re-operations will be presented. Where appropriate, statistical analysis will be performed using SPSS software (SPSS, Version 30.0, SPSS Inc., USA), while statistical significance was determined at p<0.05.
Comparison will be made in between the generated cohorts ( ACL reconstruction and posteromedial meniscal repair intervention group vs ACL reconstruction and posteromedial meniscal repair control group)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/11/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 28272 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 44485 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 319615 0
Self funded/Unfunded
Name [1] 319615 0
not applicable
Country [1] 319615 0
Primary sponsor type
Other Collaborative groups
Name
Perth Orthopaedic and Sports Medicine Research Institute
Address
Country
Australia
Secondary sponsor category [1] 322121 0
None
Name [1] 322121 0
Address [1] 322121 0
Country [1] 322121 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318177 0
Ramsay Health Care WA / SA Human Research Ethics Committee
Ethics committee address [1] 318177 0
Ethics committee country [1] 318177 0
Australia
Date submitted for ethics approval [1] 318177 0
01/10/2025
Approval date [1] 318177 0
Ethics approval number [1] 318177 0

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

Contacts
Principal investigator
Name 143366 0
A/Prof Ross Radic
Address 143366 0
Perth Orthopaedics & Sports Medicine Centre 1/1 Havelock Street, West Perth Western Australia, 6009
Country 143366 0
Australia
Phone 143366 0
+61 403322115
Fax 143366 0
Email 143366 0
[email protected]
Contact person for public queries
Name 143367 0
Ross Radic
Address 143367 0
Perth Orthopaedics & Sports Medicine Centre 1/1 Havelock Street, West Perth Western Australia, 6009
Country 143367 0
Australia
Phone 143367 0
+61 892124200
Fax 143367 0
Email 143367 0
[email protected]
Contact person for scientific queries
Name 143368 0
Ross Radic
Address 143368 0
Perth Orthopaedics & Sports Medicine Centre 1/1 Havelock Street, West Perth Western Australia, 6009
Country 143368 0
Australia
Phone 143368 0
+61 892124200
Fax 143368 0
Email 143368 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    Study Protocol_LA in posterior knee_v3.docx
Informed consent form    PIC Ramsay_v3.doc


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.