RecruitingACTRN12613000983707

A controlled comparison of three anaesthetic techniques for the total knee replacement surgery

A double blinded, randomised, controlled proof of concept study to compare postoperative analgesic and mobilisation outcomes of local infiltration analgesia, single shot femoral nerve block and intrathecal morphine in primary total knee arthroplasty

Sponsor

International Musculoskeletal Research Institute

Enrollment

45 participants

Start Date

Oct 30, 2013

Study Type

Interventional

Conditions

Osteoarthritis of the knee requiring elective total knee replacement Pain requiring analgesia following elective total knee replacements.

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

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares three types of pain control used during and after total knee replacement surgery. Having a knee replaced is a major surgery, and managing pain well afterwards helps patients recover faster. The three methods being compared are: (1) locally administered anaesthesia injected around the knee joint, (2) spinal anaesthesia (an injection in the back to numb the lower body), and (3) a femoral nerve block (numbing the main nerve in the thigh). Researchers will compare how much pain medication each group needs after surgery. You may be eligible if: - You are between 40 and 75 years old - You are having a planned (elective) primary total knee replacement for the first time - You have a BMI (body mass index) below 40 - You are able to walk independently before the surgery - You are male or female You may NOT be eligible if: - You have neuropathic pain or already take strong opioid pain medications (more than 30mg morphine/day or equivalent) - You have a mental illness, intellectual disability, or active drug or alcohol problem - You have a nerve or movement disorder in the leg being operated on, or a history of stroke - You have a condition that makes spinal anaesthesia or a nerve block unsafe or unsuitable - You are on immunosuppressive medications or taking high-dose steroids - You are allergic to anti-inflammatory medications (NSAIDs) Talk to your doctor about whether this trial might be right for you.

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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

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.

Locations(1)

SA, Australia

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ACTRN12613000983707