ACTRN12609000526279.
Trial name or title | Ultrasound‐guided femoral nerve block using 1% ropivacaine as a method of pain control in patients who present to emergency with a fractured hip |
Methods | Parallel RCT Open label Approved by the ethics committee |
Participants | Inclusion criteria: 18 years or older with radiological proof of fractured neck of femur Exclusion criteria: women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study, < 18 years old, allergy to ropivacaine, allergy to paracetamol and morphine, anticoagulated patients and those with significant coagulation abnormalities that increase their risk of bleeding. localized injection site infection. neurological deficits in the distribution of the femoral nerve noted, consent denied, documented severe hepatic disease, unable to give consent themselves, history of heart block or on amiodarone, acute cardiac event in the last 3 months |
Interventions |
Treatment group: An ultrasound‐guided femoral nerve block will be placed with 1% ropivacaine. An ultrasound vascular probe is placed to locate structures anatomically: The main structures were the femoral nerve itself, the femoral artery and vein and the fascia iliaca. Then under real‐time ultrasound guidance via an out‐of‐plane approach, 15 mL of 1% ropivacaine is injected around the femoral nerve as visualized. A 2‐person technique is employed with the needle attached to the syringe of ropivacaine via a 90 cm minimum volume extension set. The probe and needle operator is present along with an assistant who injects the anaesthetic. Digital pressure is then placed for 30 seconds just distal to the injection site. The entire procedure takes about 15 to 20 minutes. Objective measure of the nerve block is assessed at 30 minutes by testing sensation over the anterolateral aspect of the thigh Control group: Both study and control groups will receive regular oral tablet paracetamol 1 G every 4 to 6 hours to a maximum dose of 4 G in 24 hours and parenteral (intravenous) morphine as required for pain control |
Outcomes | Primary outcome: morphine use in patients for both groups at 24 hours Secondary outcomes: pain scores and subsequent pain scores to be looked at in each group and compared over the first 12 hours. Scores will range from 0 to 10, with 10 indicating the worst pain. Pain scores in both groups will be assessed at enrolment into the study, 30 minutes after enrolment or after nerve block has been given, then at 4 then 8 then 12 hours after enrolment |
Starting date | 04/04/2009 |
Contact information | Dr Edmond Park, Emergency Department, St Vincents Hospital, Victoria Street, Darlinghurst 2010 New South Wales +61 2 8382 2040, epark@stvincents.com.au |
Notes | Recruiting |