12 Versus 20 mL PCB for D&E Cervical Prep

NCT03356145 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-43789
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

paracervical block; abortion; dilation and evacuation; cervical preparation

Outcome Measures

Primary Outcomes (1)

• Pain Immediately Following Dilator Insertion

  The primary objective is to determine pain perceived immediately following dilator insertion measured by Visual Analogue Scale (VAS) (0-100mm; 0 being no pain, 100 being worst pain imaginable).

  Time of dilator insertion (less than 1 minute to assess pain)

Secondary Outcomes (6)

• Anticipated Pain Immediately Prior to Dilator Insertion

  Up to 1 minute to complete survey

• Patient Global Satisfaction Score

  Up to 1 minute to complete survey

• Total Procedure Time

  Up to 10 minutes

• Physician-reported Ease of Insertion

  Up to 1 minute to complete survey

• Count of Participants With Procedural Complications

  Up to 10 minutes

Study Arms (2)

12 mL arm

EXPERIMENTAL

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

Drug: 12 mL paracervical block

20 mL arm

ACTIVE COMPARATOR

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

Drug: 20 mL paracervical block

Interventions

12 mL paracervical block DRUG

Injection of 12 mL of lidocaine

12 mL arm

20 mL paracervical block DRUG

Injection of 20 mL of lidocaine

20 mL arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 34352829 DERIVED

MeSH Terms

Conditions

Pain; Dilatation, Pathologic

Interventions

Anesthesia, Obstetrical

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Principal Investigator
• Organization: Stanford University

gynresearch@stanford.edu

650-497-5175

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The provider and staff will be aware of arm allocation, but participants will remain blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to one of two study arms via computer-generated block randomization using REDCap software.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 29, 2017
• Study Start: January 1, 2017
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: January 23, 2024
• Results First Posted: October 19, 2021

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)