Abstract
To whom it may Concern
We would like to thank you for taking the time to respond to our study. However, we would like to clarify and answer the points raised.
We asked ŠÚKL (Štátny Ústav pre Kontrolu Liečiv - State Institute for Drug Control) Slovak authority of EMA (European Medicines Agency), agency responsible for registration of clinical trials in Slovak Republic, before starting the study. After review of complete documentation, it was decided that our study did not meet the criteria of an interventional clinical trial, but falls under biomedical research and therefore did not need any registration according to current legislation.
CONSORT flow diagram was attached to the article during the submission, and it is possible to reach it through Global Spine Journal.
The study design was double blinded parallel group placebo controlled as mentioned in the article. Only pharmacist who prepared study samples and chief of hospital pharmacy department knew exact content of every syringe. They were also responsible for randomisation and preparation of solutions, but they were not directly involved in the treatment. No one else had access to this information 30 days after allocation of the last patient in the study.
We recorded VAS score on a scale of 0 to 10 and evaluated if it was a statistically significant difference or not. We did not evaluate if there was any clinically significant difference. We measured VAS in the recovery room every 5 minutes. The reason was, that we wanted to capture dynamic changes of VAS when ESP block was wearing off. We also measured VAS on 2th and fourth week after surgery, while VAS measurement is included in PROST questionnaire, as it is mentioned in methodology in our article.
Our primary objective was “measuring opioid consumption and VAS during first 48 hours” not “at 48 hours”. In our study we found out that during first 48 hours there is only statistically significant difference of opioid consumption between groups, in PACU (Post Anaesthesia Care Unit) and that is what we also discussed and concluded. After the PACU period the opioid consumption in both groups was minimal, actually most of the patients do not need any morphine at all. Probably, the non steroid analgesia protocol in the study was too robust.
We would like to thank you again for your keen interest and perceptive comments for our research and hope our response satisfies your queries.
Sincerely
