Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial

Schivone, Gillian B.; Lerma, Klaira; Montgomery, C; Wright, Paul; Conti, Jennifer; Blumenthal, Paul D.; Shaw, Kate A.

doi:10.1016/j.contraception.2018.11.013

Cited by 8 publications

(6 citation statements)

References 15 publications

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“…We observed that pain reported with osmotic dilator insertion was similar to a prior study at our institution. 6 We also found that pain with paracervical block administration was similar to that reported in prior studies 3,4,6,8 at 46 and 55 mm for 12-mL and 20-mL paracervical block, respectively.…”

Section: Discussionsupporting

confidence: 88%

“…(Obstet Gynecol 2021;138:443-8) DOI: 10.1097/AOG.0000000000004485 T he paracervical block is a widely used technique for pain management in gynecologic procedures. 1,2 Although a painful procedure in and of itself, with reported pain of 27-56 mm on a 100 mm visual analog scale (VAS), [3][4][5][6][7][8][9] paracervical block, when compared with a sham block, has been shown to decrease reported pain with various gynecologic procedures, including intrauterine device (IUD) insertion, 4,9 firsttrimester aspiration abortion, 3 and osmotic dilator insertion. 5 A 2009 survey of National Abortion Federation clinicians illustrated that, although paracervical block is nearly universal, the volume of anesthetic used for paracervical block in first-trimester abortion procedures significantly varies.…”

Section: Resultsmentioning

confidence: 99%

“…Given the evidence supporting the use of paracervical block for osmotic dilator insertion 5,6 we chose not to include a placebo control group in our study. We found higher pain scores with osmotic dilator insertion as compared with Soon et al 5 and Mercier et al 15 but similar to Schivone et al, 6 conducted at our institution; however, the lack of a placebo group in our study is a potential limitation.…”

Section: Discussionmentioning

confidence: 99%

“…We powered our study on the primary outcome of reported pain with osmotic dilator insertion using a 100 mm VAS. We defined a noninferiority margin of 15 mm, as this is well established as a clinically significant difference on the 100 mm VAS, 3,4,6,7 and assumed an SD of 28. 4 With a one-sided alpha of 0.05 and power of 80%, we estimated 88 participants would be required to show that 12 mL was noninferior to 20 mL.…”

Section: Methodsmentioning

confidence: 99%

“…The remaining lidocaine was then injected into the cervicovaginal junction, at a depth of 1.5-2 cm, in two equal aliquots at 4 and 8 o'clock. [3][4][5][6][7][8] No wait time was required before insertion of osmotic dilators. 8 Procedures were performed by Complex Family Planning faculty and fellows or Obstetrics and Gynecology residents under faculty supervision.…”

Section: Methodsmentioning

confidence: 99%

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A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement

Shaw

Lerma

Hughes

et al. 2021

Obstetrics &Amp; Gynecology

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OBJECTIVE: To evaluate whether a 12-mL paracervical block is noninferior to a 20-mL block in reducing pain with osmotic dilator insertion. METHODS: In this single-blinded noninferiority trial, we randomized individuals undergoing insertion of osmotic dilators before second-trimester abortion to receive either a 12-mL or 20-mL 1% lidocaine paracervical block. The primary outcome was pain immediately after insertion of osmotic dilators. Prespecified secondary outcomes included pain with paracervical block administration, overall pain, and side effects, with 88 participants being required for a noninferiority margin of 15 mm on a 100-mm visual analog scale assuming an SD of 28. We analyzed data using Wilcoxon rank sum, χ2, and t tests and performed analysis of variance to account for repeated measures. Secondary analysis included multivariable regression to explore potential confounders. RESULTS: From January 2018 to October 2020, of 232 eligible individuals, 174 were approached and 96 randomized (48 participants to each group); 91 were available for analysis (45: 12 mL, 46: 20 mL). Group demographics were similar, with a mean gestation of 21 weeks and four osmotic dilators placed. The 12-mL paracervical block was noninferior to the 20-mL paracervical block for pain with osmotic dilator insertion with a difference in means of −1.36 (95% CI −12.56 to 9.85) favoring 12 mL. Median pain scores after dilator placement were 47 mm (interquartile range 22–68) and 50 mm (interquartile range 27–67) in 12-mL compared with 20-mL paracervical block, respectively (P=.81). No difference was seen in median pain at baseline, with paracervical block administration, postprocedure or with overall pain or experience. At least one lidocaine-related side effect occurred in 4% of participants in the 12-mL group compared with 13% for those receiving 20 mL (P=.15), with metallic taste, ringing in ears, and lightheadedness being most common. CONCLUSION: A 12-mL paracervical block is noninferior to a 20-mL block for pain reduction with osmotic dilator insertion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03356145.

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Section: Discussionsupporting

confidence: 88%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 3 more Smart Citations

A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement

Shaw

Lerma

Hughes

et al. 2021

Obstetrics &Amp; Gynecology

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Current and potential methods for second trimester abortion

Lerma

Blumenthal

2020

Best Practice & Research Clinical Obstetrics & Gynaecol

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Gabapentin for pain management after osmotic dilator insertion and prior to dilation and evacuation: A randomized controlled trial

Creinin

Schimmoeller²,

Matulich

et al. 2020

Contraception

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Objective: To evaluate if gabapentin 600 mg reduces pain after osmotic dilator placement the day before a dilation and evacuation (D&E) procedure. Study Design: We conducted a double-blind, placebo-controlled, randomized (stratified by vaginal parity) trial among women undergoing osmotic dilator placement before D&E at 15 to 23 5/7 weeks gestation. Subjects received gabapentin 600 mg or placebo 30 minutes before dilator placement, with re-dosing 8 hours later. We assessed pain after dilator placement using a numeric rating scale (NRS; scale 0-10) at 5 minutes, 2, 4, and 8 hours, and at presentation for D&E. The primary outcome was median NRS pain score change from baseline to 8 hours after dilator placement. Secondary outcomes included gabapentin-related side effects and analgesic use. Results: Of 121 randomized women, we excluded three subjects (allergic reaction [placebo], randomization error, no NRS data), leaving 60 gabapentin and 58 placebo subjects. Of 110 (93%) women who provided 8-hour data, median pain score changes from baseline did not differ between gabapentin and placebo groups overall (2 vs. 2.5, p=0.52), in vaginally nulliparous women (2 vs. 4, p=0.10) or in parous women (2 vs. 1.5, p=0.37). We found no statistically significant differences in median pain score change from baseline to any timepoint overall or when stratified by parity. Beginning at 2 hours after dilator placement, more gabapentin than placebo users experienced dizziness (29/53[55%] vs. 11/53[21%], p=0.001) and tiredness (34/54[63%] vs. 17/54[31%], p=0.002). The proportion of women using narcotics did not differ between gabapentin (35/60[58%]) or placebo (40/58[69%]) users (p=0.26). 3 Conclusions: Gabapentin does not reduce pain with overnight osmotic dilator placement prior to D&E and causes drug-related side effects.

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Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial

Cited by 8 publications

References 15 publications

A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement

A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement

Current and potential methods for second trimester abortion

Gabapentin for pain management after osmotic dilator insertion and prior to dilation and evacuation: A randomized controlled trial

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