None listed
Conditions
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.
Interventions
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.
Sponsors
Simon Young (Waitemata DHB)
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 No maximum
Healthy volunteers
No
Inclusion criteria
All patients over the age of 18 giving written consent Primary anterior cruciate ligament reconstruction (ACLR) for ACL rupture
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)
Outcome results
None listed