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, 32mm)] 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.
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Authors | Regina-Maria Renner, Alison B Edelman, Mark D Nichols, Jeffrey T Jensen, Jeong Y Lim, Paula H Bednarek |
Journal | Contraception
(Contraception)
Vol. 94
Issue 5
Pg. 461-466
(11 2016)
ISSN: 1879-0518 [Electronic] United States |
PMID | 27235677
(Publication Type: Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2016 Elsevier Inc. All rights reserved. |
Chemical References |
- Anesthetics, Local
- Lidocaine
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Topics |
- Abortion, Induced
(methods)
- Adult
- Anesthesia, Obstetrical
(methods)
- Anesthetics, Local
(therapeutic use)
- Female
- Humans
- Labor Stage, First
- Lidocaine
(therapeutic use)
- Oregon
- Pain
(drug therapy)
- Pain Management
- Pain Measurement
- Pregnancy
- Pregnancy Trimester, First
- Single-Blind Method
- Time Factors
- Treatment Outcome
- Young Adult
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