Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000145404p
Ethics application status
Submitted, not yet approved
Date submitted
19/01/2025
Date registered
7/02/2025
Date last updated
7/02/2025
Date data sharing statement initially provided
7/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
VOLT Anterior Cruciate Ligament (ACL) Study: Intraosseous Regional Administration of Diclofenac in Anterior Cruciate Ligament Reconstruction in Patients with Anterior Cruciate Ligament Rupture
Scientific title
A prospective, double-blinded, randomised controlled trial of Intraosseous Regional Diclofenac vs. Intravenous Diclofenac for Postoperative Pain Management in Anterior Cruciate Ligament Reconstruction in patients with Anterior Cruciate Ligament Rupture
Secondary ID [1] 313295 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament injury 335631 0
Postoperative pain 335633 0
Condition category
Condition code
Injuries and Accidents 332192 332192 0 0
Other injuries and accidents
Anaesthesiology 332193 332193 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For ACL reconstruction, the intervention group will receive regional (intraosseous) administration of 75mg diclofenac immediately prior to skin incision and after tourniquet inflation. A blinded surgeon will administer the medication prepared by an unblinded researcher (not the surgeon or anaesthetist) according to the participant's group allocation). The unblinded researcher will observe and ensure adherence to the intervention.
Intervention code [1] 329959 0
Treatment: Drugs
Comparator / control treatment
For ACL reconstruction, the control group will receive systemic (intravenous) administration of 75mg diclofenac infusion over 2 minutes finishing at least 3 minutes prior to tourniquet inflation. A blinded anaesthetist will administer the medication prepared by an unblinded researcher (not the surgeon or anaesthetist) according to the participant's group allocation). The unblinded researcher will observe and ensure adherence to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 339880 0
Pain scores at rest as measured on a 100mm analogue scale
Timepoint [1] 339880 0
Baseline, 1 hour, 2 hours, 3 hours, 4+ hours if not yet discharged up until discharge. Also, twice daily measurements at 8am and 6pm from post op days 1 to 7.
Primary outcome [2] 340512 0
Pain scores at mobilisation as measured on a 100mm analogue scale
Timepoint [2] 340512 0
Baseline, 1 hour, 2 hours, 3 hours, 4+ hours if not yet discharged up until discharge. Also, twice daily measurements at 8am and 6pm from post op days 1 to 7.
Secondary outcome [1] 441737 0
Mean daily morphine milligram equivalent (MME)
Timepoint [1] 441737 0
Immediately post-operatively then daily to post-op day 7
Secondary outcome [2] 441739 0
Knee function and recovery, particularly the function and symptoms of the knee. This will be assessed alongside the KOOS-QoL score as a composite outcome for knee function.
Timepoint [2] 441739 0
Post-operatively weeks 2 and 8
Secondary outcome [3] 441740 0
Knee function and recovery, particularly the impact of knee issues on a person's overall quality of life. This will be assessed alongside the Lysholm score as a composite outcome for knee function.
Timepoint [3] 441740 0
Post-operatively weeks 2 and 8
Secondary outcome [4] 441741 0
Early postoperative health status of patients
Timepoint [4] 441741 0
1 day post-operatively
Secondary outcome [5] 441743 0
How pain has affected the patient’s quality of sleep over the past 24 hours
Timepoint [5] 441743 0
Daily post-operatively day 1 to 7

Eligibility
Key inclusion criteria
All patients over the age of 18 giving written consent
Primary anterior cruciate ligament reconstruction (ACLR) for ACL rupture
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No capacity to consent to research project
- Allergy to NSAIDs
- History of severe asthma
- History of haemorrhagic diathesis
- History of gastrointestinal issues (peptic ulcers, gastrointestinal bleeding, and other significant gastrointestinal disorders at higher risk of complications following NSAID use)
- Significant renal impairment (GFR<30 mL/min/1.73m2)
- Severe hepatic disease
- Significant cardiac history
- Pregnancy or breastfeeding
- Clinically poorly controlled mental health
- Prior ipsilateral ACL surgery
- Patients with lower limbs not amenable to effective tourniquet use
- Precluded from having general anaesthesia
- Preoperative hypertension (systolic BP >180 mmHg)
- Significant use of analgesia at baseline (eg opioid dependence)

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 - computerised sequence generation (random number generator), in 1:1 ratio
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
To reduce the risk of a type 2 error, we have decided to power the study to detect a 15mm difference in VAS-pain at 1 hour post op, with an expected standard deviation of 20mm based on previous studies mentioned above. With a power of 80% and a = 0.05 this gives a total of 28 patients per group. 30 patients will be recruited in each group to account for any loss of follow-up, although based on our previous study in TKA we expect the loss to follow up to be minimal.

Means, standard deviation, and 95% confidence intervals will be calculated for the participant VAS-pain scores at each recorded time interval as the primary objective of the study. A general linear model or generalised linear mixed model, followed by independent two-sample t-test or Wilcoxon non-parametric rank sum test will be used to analyse the data. VAS-pain scores will be pooled according to the appropriate study group for comparison between the study arms. An MCID of 15 mm will be used to determine a clinically important difference in pain management.
For secondary objectives, independent two-sample t-test or Wilcoxon non-parametric rank sum test will be used to compare means of MME, QoR-15, sleep, Lysholm, and KOOS-QoL scores between the intervention group and control group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26727 0
New Zealand
State/province [1] 26727 0

Funding & Sponsors
Funding source category [1] 318213 0
Self funded/Unfunded
Name [1] 318213 0
Country [1] 318213 0
Primary sponsor type
Individual
Name
Simon Young (Waitemata DHB)
Address
Country
New Zealand
Secondary sponsor category [1] 320063 0
None
Name [1] 320063 0
Address [1] 320063 0
Country [1] 320063 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316433 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 316433 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 316433 0
New Zealand
Date submitted for ethics approval [1] 316433 0
15/01/2025
Approval date [1] 316433 0
Ethics approval number [1] 316433 0

Summary
Brief summary
This study aims to investigate the effects of a new method of pain relief administration to treat operative and postoperative pain. The primary hypothesis is that patient’s undergoing ACL reconstruction surgery who receive diclofenac (Voltaren™) intraosseously (through the bone) will experience lower levels of pain in the immediate post operative period compared to patients who receive diclofenac systemically (intravenously). Patricipants in the study will be randomly assigned to either the intraosseous or intravenous group to assess the impact of both methods in affecting pain. The study seeks to understand whether intraosseous diclofenac administration in ACL reconstruction surgery reduces pain and ultimately improves quality of life and functional outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137882 0
A/Prof Simon Young
Address 137882 0
Southern Cross Hospital North Harbour, 232 Wairau Road, Glenfield, Auckland 0627
Country 137882 0
New Zealand
Phone 137882 0
+64 21616183
Fax 137882 0
Email 137882 0
[email protected]
Contact person for public queries
Name 137883 0
Simon Young
Address 137883 0
Southern Cross Hospital North Harbour, 232 Wairau Road, Glenfield, Auckland 0627
Country 137883 0
New Zealand
Phone 137883 0
+64 21616183
Fax 137883 0
Email 137883 0
[email protected]
Contact person for scientific queries
Name 137884 0
Simon Young
Address 137884 0
Southern Cross Hospital North Harbour, 232 Wairau Road, Glenfield, Auckland 0627
Country 137884 0
New Zealand
Phone 137884 0
+64 21616183
Fax 137884 0
Email 137884 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


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.