None listed
Conditions
Brief summary
During Knee replacement surgery there are different techniques that the doctor can use to anaesthetise the patient during their surgery and differing options for managing pain relief immediately following surgery. The aim of this study is to compare 3 ways of doing this and to work out which way is best by looking at the pain relief needed by the patients in the different groups after their surgery. The 3 different ways are: 1. Locally Administered Anaesthesia 2. Spinal Anaesthesia 3. Femoral Nerve Block
Interventions
Study Arm-1 Local Infiltration Analgesia Randomized Arm
2.5mL of 0.5% bupivacaine (heavy) placed in the intrathecal space using a 25G Whitacre needle.
Ultrasound identification of the femoral nerve and direct guidance of a needle to deposit 20mL of normal saline around the femoral nerve. This will be performed after the spinal anaesthetic to minimize patient discomfort.
Intraoperative local infiltration of ropivacaine 0.2% into the knee joint through an indwelling catheter. This is injected unde
Study Arm-1 Local Infiltration Analgesia Randomized Arm 2.5mL of 0.5% bupivacaine (heavy) placed in the intrathecal space using a 25G Whitacre needle. Ultrasound identification of the femoral nerve and direct guidance of a needle to deposit 20mL of normal saline around the femoral nerve. This will be performed after the spinal anaesthetic to minimize patient discomfort. Intraoperative local infiltration of ropivacaine 0.2% into the knee joint through an indwelling catheter. This is injected under direct vision into all tissues traumatized during the operation. Study Arm-2 Single Shot Femoral Nerve Block Randomized Arm 2.5mL of 0.5% bupivacaine (heavy) and placed in the intrathecal space using a 25G Whitacre needle. Ultrasound identification of the femoral nerve and direct guidance of a needle to deposit 20mL 0.2% ropivacaine around the femoral nerve. This will be performed after the spinal anaesthetic to minimize patient discomfort. Intraoperative local infiltration of normal saline into the knee joint through an indwelling catheter. This is injected under direct vision into all tissues traumatized during the operation. Study Arm-3 Spinal Anaesthesia i.e. intrathecal Morphine Randomized Arm 2.5mL of 0.5% bupivacaine (heavy) and 200mcg Intrathecal morphine hydrochloride placed in the intrathecal space using a 25G Whitacre needle. Ultrasound identification of the femoral nerve and direct guidance of a needle to deposit 20mL of normal saline around the femoral nerve. This will be performed after the spinal anaesthetic to minimize patient discomfort. Intraoperative local infiltration of normal saline into the knee joint through an indwelling catheter. This is injected under direct vision into all tissues traumatized during the operation. All study arms will employ Elastomeric Infusion in accordance with the standard TKR protocol followed by RGH.
Sponsors
International Musculoskeletal Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Elective primary unilateral total knee arthroplasty Age 40-75 years BMI <40 Ability to self-mobilize Patient understands the conditions of the study and are willing and able to give written informed consent to participate in the study including prescribed follow-ups Patient is of legal age and skeletally mature
Exclusion criteria
Previous involvement in this study Neuropathic pain or opioid tolerance (defined as use of >30mg oral morphine/day or equivalent – fentanyl patch 12mcg/hr., buprenorphine patch 20mcg/hr., oral oxycodone >20mg/day) Patient has an emotional or neurological condition that would pre-empt their willingness to participate in the study including mental illness, intellectual disability, and drug or alcohol abuse. Sensory and/or motor disorders in the operated limb, history of stroke of major neurological deficit. Contraindication to spinal anaesthesia (coagulopathy, sepsis, local infection, patient refusal, spinal defects, previous laminectomy) Contraindication to femoral nerve block (patient refusal, local infection, femoral neuropathy) Patient is immunosuppressed or receiving high doses of corticosteroids. Contraindication to NSAIDs (allergy, moderate to severe renal insufficiency).
Outcome results
None listed