Clinical evaluation of XaraColl(®), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies.

J Pain Res · 2012 · PMC3392712 · PMID 22792007

Europe PMC DOI

hedged sentences

0.0130

closest p · 0.3× alpha

0.0970

boldest claim

The sentences

highly significantP = 0.013actually significant

Importantly, when taking both pain and use of rescue medication into account, the I-SPI-TOpA analyses showed a statistically significant treatment effect for both individual studies and was highly significant for the pooled dataset ( P = 0.013, P = 0.005, and P < 0.0001 for study 1, 2, and pooled, respectively).

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a trend toward significanceP = 0.094so close (0.05 < p ≤ 0.1)

However, for study 2, the reductions in TOpA and I-SPI-TOpA both showed a trend toward significance ( P = 0.094 and 0.078, respectively).

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a trend towards significanceP = 0.097so close (0.05 < p ≤ 0.1)

Through 48 hours, the combined I-SPI-TOpA endpoint continued to show a statistically significant treatment effect in study 2 ( P = 0.040) and the pooled dataset ( P = 0.008), with a trend towards significance in study 1 ( P = 0.097).

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