12 Versus 20 mL PCB for D&E Cervical Prep

NCT ID: NCT03356145

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-10-15

Brief Summary

More research is needed to investigate methods of pain control for cervical preparation for abortion procedures. Women report pain with paracervical block injection as well as with osmotic dilator placement. This study seeks to compare a 12 mL, 2-site 1% plain lidocaine paracervical block for pain control during cervical preparation (osmotic dilator insertion) for Dilation and Evacuation (D&E) to a 20 mL 1% lidocaine 2-site paracervical block.

Detailed Description

This is a non-inferiority, single blinded, randomized controlled trial.This study will use a 2-site, 12 mL 1% plain lidocaine injection paracervical block (PCB) technique (2 mL for tenaculum placement, 10 mL for paracervical block) will provide non-inferior pain control compared to a previously established 2-site, 20 mL 1% lidocaine injection PCB (2 mL for tenaculum placement, 18 mL for paracervical block) when administered for dilation pain control during cervical preparation.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

12 mL arm

Intervention:

• Syringe loaded with 12 mL of 1% lidocaine (120 mg); 22-gauge spinal needle
• 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix
• The tenaculum is immediately placed at the previously injected site
• The remaining 10 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal)
• No wait time between injection and dilator insertion

Group Type: EXPERIMENTAL

12 mL paracervical block

Intervention Type: DRUG

Injection of 12 mL of lidocaine

20 mL arm

Intervention:

• Syringe loaded with 20 mL of 1% lidocaine (120 mg); 22-gauge spinal needle
• 2 mL injected at the tenaculum site, either 6 or 12 o'clock superficially into the cervix
• The tenaculum is immediately placed at the previously injected site
• The remaining 18 mL are slowly injected into the cervicovaginal junction in two equal aliquots at 4 and 8 o'clock; the injection is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal)
• No wait time between injection and dilator insertion

Group Type: ACTIVE_COMPARATOR

20 mL paracervical block

Intervention Type: DRUG

Injection of 20 mL of lidocaine

Interventions

12 mL paracervical block

Injection of 12 mL of lidocaine

Intervention Type: DRUG

20 mL paracervical block

Injection of 20 mL of lidocaine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women 18 and older
• Intrauterine pregnancy ≥16 weeks gestation
• English speaking competency
• Willing and able to sign consent forms
• Agree to comply with study procedures

Exclusion Criteria

• Women less than 18 years of age
• IV conscious sedation
• Known allergy to study medication (lidocaine)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

Shaw KA, Lerma K, Hughes T, Hastings C, Fok WK, Blumenthal PD. A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):443-448. doi: 10.1097/AOG.0000000000004485.

Reference Type: DERIVED

PMID: 34352829 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-43789

Identifier Type: -

Identifier Source: org_study_id