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Re: OB: NEJM Article On AnalgesiaFrom: Betsy Hyde (elishyde@mindspring.com)Thu Feb 17 15:48:00 2005
Perhaps I am missing something, but does the study design seem very poor to anyone other than me? Does a reading of the entire study clarify this seemingly poor design?
> Methods We conducted a randomized trial of 750 nulliparous women at And how dilated were they when they made the first request for analgesia? From the abstract, it appears that they were randomized when they were either less than 4 cm or had SROM, with or without labor. With good randomization, the groups should theoretically be of equal dilatation when they make the first request for analgesia...but what *was* the average dilatation? In my practice, women rarely ask for pain relief prior to 4 cm.
> Epidural analgesia It would be very unusual to have intrathecal narcotics, followed by a 2nd request for analgesia, and STILL be less than 4cm dilated when they got the epidural. Perhaps I am missing something, but the media is saying "no problem with epidurals at less than 4cm". I'm not sure this is what the study design says, or is it?
> Results The rate of cesarean delivery was not significantly different Does the study show how many in each group actually *got* epidurals vs just the initial intervention? Do the authors present the mean dilatation at which each group actually got their epidurals?
> The incidence of one-minute Apgar scores below 7 was The incidence of 1 minute apgar scores <7 of 16.7 - 24.0 percent sounds incredibly high to me. Although there are probably ethical considerations that would make most IRBs reluctant to approve the study design, it seems that the true design would be no pain relief other than epidurals, with women randomized to receive epidurals prior to 4cm vs >4cm. I just don't understand the study design of the NEJM paper at all, and feel that the media comments are perhaps not accurate. I really think I need to read the entire study before accepting the conclusions.
-- Betsy Hyde CNM Branford, CT
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