Abstract
Objectives
Our objective was to evaluate two different aspects of the paracervical block (PCB)
technique for first trimester surgical abortion, to compare a 3-min wait prior to
cervical dilation to no wait and to compare four-site with two-site injection.
Study design
We conducted two consecutive randomized, single-blinded noninferiority trials. In
the first trial, women <11 weeks gestational age received a 20-mL 1% buffered lidocaine four-site PCB with
either a 3-min wait between PCB injection and dilation or no wait. In the second trial,
we compared a four-site with a two-site PCB. We evaluated dilation pain [100-mm visual
analogue scale (VAS)] as the primary outcome. Secondary outcomes included pain at
additional time points, anxiety, satisfaction and adverse events.
Results
Both trials fully enrolled (total n=332). Results were inconclusive as to whether no wait was noninferior to waiting 3-min
prior to cervical dilation for dilation pain [VAS: 63 mm (SD, 24 mm) vs. 56 mm (SD,
32 mm)] and as to whether a two-site PCB was noninferior to a four-site block [VAS: 68
mm (SD, 21 mm) vs. 60 mm (SD, 30 mm)]. Noninferiority analysis was inconclusive because
the confidence interval of the mean pain score difference between groups included
the predefined inferiority margin of 13-mm pain difference. Superiority analysis showed
the four-site PCB to be superior to the two-site PCB.
Conclusion
It remained inconclusive whether a 3-min wait time between PCB and cervical dilation
provides noninferior pain control for first trimester surgical abortion. However,
a four-site PCB appeared to be superior to a two-site PCB.
Implications
It remained inconclusive whether a 3-min wait time between PCB and cervical dilation
or using a two-site instead of a four-site PCB provided noninferior pain control for
first trimester surgical abortion. This study did not assess whether the combination
of the two separate factors provides additive benefit.
Keywords
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Article info
Publication history
Published online: May 25, 2016
Accepted:
May 21,
2016
Received in revised form:
May 18,
2016
Received:
November 18,
2015
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
