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- W2605645751 abstract "We thank Haque and Fregene for their interest in our study 1. As stipulated in our protocol 2, patients taking non-steroidal anti-inflammatory drugs (NSAID) pre-operatively continued to take these medications. No NSAIDs were commenced de novo in either treatment group during the study period. Whilst we agree that data relating to NSAID use could have provided additional information, we did not record this during the study period and unfortunately are unable to provide this information retrospectively. The non-significant difference in pre-operative paracetamol consumption referred to the single pre-medicant dose prescribed as part of the study protocol and not patients’ usual medications. Therefore, whilst we understand the suggestion about relative pain scores, this would not apply. As the study was randomised, we would not have expected significant differences between groups for this parameter, though agree that it could have provided further information about the baseline pain status of the study groups. We agree that any neuropraxia is a serious adverse event and reported this as such. The patient in this case made a full recovery. The nerve palsy was discussed at length with the surgical team who did not consider it likely to have resulted from the study intervention. The incidence of surgery-related femoral nerve palsy is reported as 0.1–2.4% with a mean of 0.8% 3. It is therefore difficult in practice to establish whether surgery or anaesthesia is causative. We accept the issue of sham blocks remains controversial. By virtue of using ultrasound to inject lateral and distant to the nerve, fascia iliaca block is considered a relatively low-risk procedure. As such, it is approved for use by non-medical practitioners in the UK 4. Our study underwent extensive peer review via grant applications and publication of the protocol, and sham fascia iliaca blocks have also recently been performed by other investigators 5. At the time of study design, we did not know that ultrasound-guided fascia iliaca block would be inferior to spinal morphine hence the performance of the trial. Our study was designed and underwent ethical review in October 2010. It has since been suggested that the use of any sham treatment be evaluated using the ‘SHAM tool’ 6. This aims to establish and minimise any risk of harm to the patient. This tool, first published in 2011, can aid investigators in the decision to use sham blocks in future study designs. No block is without risk, and the balance of risk and benefit is always a decision based on an individual patient guided by the best available evidence. Further work is still required to establish the optimal ultrasound-guided fascia iliaca block approach, and which hip surgery benefits most, if at all, from this technique in order to help clinicians when making these decisions." @default.
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- W2605645751 date "2017-04-12" @default.
- W2605645751 modified "2023-10-16" @default.
- W2605645751 title "Fascia iliaca block for hip replacement - adjuvants and ethics. A reply" @default.
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- W2605645751 doi "https://doi.org/10.1111/anae.13881" @default.
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