VOLT Study: Intraosseous Regional Administration of Voltaren™ in Primary Total Knee Arthroplasty

VOLT Study: Intraosseous Regional Administration of Voltaren™ in Primary Total Knee Arthroplasty . A Prospective, Double-Blinded, Randomised Controlled Trial Comparing the Analgesic Efficacy of Intraosseous Regional Diclofenac and Intravenous Diclofenac for Postoperative Pain Management in TKA

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000196741

Acronym

VOLT

Enrollment

Registered

2022-02-04

Start date

2022-08-03

Completion date

2023-12-01

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to evaluate the effectiveness of intraosseous Diclofenac (Voltaren™) compared to systemic (intravenous) Diclofenac, in managing postoperative pain for total knee joint replacements. The overarching goal is to determine an effective method of providing postoperative pain relief so patients may recover better from their surgery and have better outcomes from their knee replacements. Intraosseous regional administration (IORA) of analgesia is a novel technique being used in New Zealand and overseas with anecdotal evidence for improved post-operative pain management following total knee joint replacements. This method involves directly injecting the study medication into the shin bone (directly into bone marrow) after inflating a tourniquet around the thigh to keep medication localised in the surgical area. This should result in greater concentrations of Diclofenac achieved in the soft tissue around the surgical site both after tourniquet inflation and after tourniquet deflation, resulting in prolonged analgesia. By-products of this effect should also include reduced systemic concentrations of the medication (leading to reduced systemic side effects of the medication), a reduction in need for rescue analgesia including opioids (which come with their own side effects), as well as improved overall postoperative outcomes for patients with better recovery following their surgery.

Interventions

Arm 1: Pre-operative single dose 75mg Diclofenac via intraosseous regional administration. The study medication will be prepared by an unblinded researcher, then administered by the study surgeon performing the surgery after tourniquet inflation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

Informed consent obtained - both written and verbal Primary total knee arthroplasty for Osteoarthritis Age greater then or equal to 18 and less than or equal to 80

Exclusion criteria

Patient lacking capacity to consent to the research project BMI greater than or equal to 40 Pregnancy or suspected pregnancy Pain Catastrophising Scale score greater than or equal to 30 points Previous infection of knee joint Rheumatoid/inflammatory arthritis Undergoing bilateral total knee replacement, revision total knee arthroplasty, or any additional procedure outside of a primary total knee arthroplasty Precluded from having general anaesthesia Patients with lower limbs not amenable to effective tourniquet use Contraindications to Diclofenac: Known allergy or hypersensitivity to Aspirin or other NSAID - including attacks of asthma, angioedema, urticaria, or acute rhinitis Severe renal disease (GFR<15 mL/min/1.73m2) Severe cardiac failure Hepatic failure Active gastric or intestinal ulcer, bleeding or perforation Recent myocardial infarction (within last 12 months) History of asthma History of haemorrhagic diathesis

Outcome results