Gillian B Schivone1, Klaira Lerma2, Corinne Montgomery3, Paul Wright4, Jennifer A Conti5, Paul D Blumenthal6, Kate A Shaw7. 1. Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: gschivone@wustl.edu. 2. Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: klerma@stanford.edu. 3. Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: corinnemontgomery@stanford.edu. 4. Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: jacquelinebarbic@gmail.com. 5. Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: jconti@stanford.edu. 6. Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: pblumen@stanford.edu. 7. Stanford University, Department of Obstetrics and Gynecology, Division of Family Planning Services and Research, 300 Pasteur Drive, HG 332, Palo Alto, CA, USA 94305. Electronic address: kateshaw@stanford.edu.
Abstract
OBJECTIVE(S): To compare pain scores during cervical dilator placement prior to dilation and evacuation (D&E) with patient-administered vaginal lidocaine gel versus lidocaine paracervical block (PCB). STUDY DESIGN: We conducted an unblinded randomized trial of women ≥18 years of age undergoing surgical abortion at ≥16 weeks' gestation in two outpatient clinics. We randomized participants to receive self-administered lidocaine gel 2% 20 mL intravaginally 15-30 min before procedure initiation or lidocaine 1% 12 mL PCB immediately prior to dilator placement. Participants rated their pain at various time points using a visual analog scale (VAS), including anticipated and baseline pain, speculum insertion, tenaculum placement, cervical dilator placement (primary outcome) and speculum removal. RESULTS: We enrolled 72 women and analyzed data for 69 participants. Sociodemographic characteristics and VAS scores at all time points, except for anticipated pain, were similar between groups. The median pain score with dilator placement was 48 mm in the gel group and 61 mm in the PCB group (p=.23). Procedure times for the gel group and PCB group were 3.7 min and 5.2 min, respectively (p<.01). Lidocaine gel was noninferior to PCB for reported pain scores (VAS) with dilator placement, with a difference in means of -8 mm (95% CI -21, 5) favoring the gel. CONCLUSIONS: Self-administration of lidocaine gel prior to placement of cervical dilators for D&E is noninferior to paracervical lidocaine block for local anesthesia and is a potential alternative to PCB for pain management with osmotic dilator placement. IMPLICATIONS: Lidocaine gel and similar products represent noninvasive, nonpainful methods of local anesthesia for a variety of outpatient gynecologic procedures. Given our noninferiority findings, if gel anesthetics are available, they should be considered as an alternative to paracervical block.
RCT Entities:
OBJECTIVE(S): To compare pain scores during cervical dilator placement prior to dilation and evacuation (D&E) with patient-administered vaginal lidocaine gel versus lidocaineparacervical block (PCB). STUDY DESIGN: We conducted an unblinded randomized trial of women ≥18 years of age undergoing surgical abortion at ≥16 weeks' gestation in two outpatient clinics. We randomized participants to receive self-administered lidocaine gel 2% 20 mL intravaginally 15-30 min before procedure initiation or lidocaine 1% 12 mL PCB immediately prior to dilator placement. Participants rated their pain at various time points using a visual analog scale (VAS), including anticipated and baseline pain, speculum insertion, tenaculum placement, cervical dilator placement (primary outcome) and speculum removal. RESULTS: We enrolled 72 women and analyzed data for 69 participants. Sociodemographic characteristics and VAS scores at all time points, except for anticipated pain, were similar between groups. The median pain score with dilator placement was 48 mm in the gel group and 61 mm in the PCB group (p=.23). Procedure times for the gel group and PCB group were 3.7 min and 5.2 min, respectively (p<.01). Lidocaine gel was noninferior to PCB for reported pain scores (VAS) with dilator placement, with a difference in means of -8 mm (95% CI -21, 5) favoring the gel. CONCLUSIONS: Self-administration of lidocaine gel prior to placement of cervical dilators for D&E is noninferior to paracervical lidocaine block for local anesthesia and is a potential alternative to PCB for pain management with osmotic dilator placement. IMPLICATIONS: Lidocaine gel and similar products represent noninvasive, nonpainful methods of local anesthesia for a variety of outpatient gynecologic procedures. Given our noninferiority findings, if gel anesthetics are available, they should be considered as an alternative to paracervical block.