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Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial.
Contraception. 2016 11; 94(5):461-466.C

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.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, OR 97239, USA. Electronic address: rerenner@bluewin.ch.Department of Obstetrics and Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, OR 97239, USA.Department of Obstetrics and Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, OR 97239, USA.Department of Obstetrics and Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, OR 97239, USA.Division of Biostatistics, Department of Public Health & Preventive Medicine, Oregon Health & Science University, Portland, OR 97239, USA.Department of Obstetrics and Gynecology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, UHN 50, Portland, OR 97239, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27235677

Citation

Renner, Regina-Maria, et al. "Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion: a Randomized Controlled Noninferiority Trial." Contraception, vol. 94, no. 5, 2016, pp. 461-466.
Renner RM, Edelman AB, Nichols MD, et al. Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial. Contraception. 2016;94(5):461-466.
Renner, R. M., Edelman, A. B., Nichols, M. D., Jensen, J. T., Lim, J. Y., & Bednarek, P. H. (2016). Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial. Contraception, 94(5), 461-466. https://doi.org/10.1016/j.contraception.2016.05.005
Renner RM, et al. Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion: a Randomized Controlled Noninferiority Trial. Contraception. 2016;94(5):461-466. PubMed PMID: 27235677.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial. AU - Renner,Regina-Maria, AU - Edelman,Alison B, AU - Nichols,Mark D, AU - Jensen,Jeffrey T, AU - Lim,Jeong Y, AU - Bednarek,Paula H, Y1 - 2016/05/25/ PY - 2015/11/18/received PY - 2016/05/18/revised PY - 2016/05/21/accepted PY - 2016/10/25/pubmed PY - 2017/10/20/medline PY - 2016/5/29/entrez KW - Abortion KW - Analgesia KW - Pain control KW - Paracervical block SP - 461 EP - 466 JF - Contraception JO - Contraception VL - 94 IS - 5 N2 - 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. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/27235677/Refining_paracervical_block_techniques_for_pain_control_in_first_trimester_surgical_abortion:_a_randomized_controlled_noninferiority_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(15)30207-9 DB - PRIME DP - Unbound Medicine ER -