12 Versus 20 mL PCB for D&E Cervical Prep

Browse trials for

• Pain 10,054
• Dilatation, Pathologic 120

Keywords

• paracervical block
• abortion
• dilation and evacuation
• cervical preparation

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 96 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Study arms

• Experimental
  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

  Drug: 12 mL paracervical block

• Active comparator
  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

  Drug: 20 mL paracervical block

Interventions

• Drug12 mL paracervical block

  Injection of 12 mL of lidocaine

• Drug20 mL paracervical block

  Injection of 20 mL of lidocaine

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

Secondary outcomes

1. Anticipated Pain Immediately Prior to Dilator Insertion

   Pain measured by VAS (0-100mm; 0 being no pain, 100 being worst pain imaginable).

   Time frame: Up to 1 minute to complete survey

2. Patient Global Satisfaction Score

   Global satisfaction (acceptability) of procedure reported by participant, measured by 0-100mm VAS; with anchors at 0 ("worse than expected"), 50 ("what I expected"), and 100 ("better than expected").

   Time frame: Up to 1 minute to complete survey

3. Total Procedure Time

   Defined as time of speculum insertion

   Time frame: Up to 10 minutes

4. Physician-reported Ease of Insertion

   Measured by VAS (0-100mm; 0 being "very easy", 100 being "very difficult").

   Time frame: Up to 1 minute to complete survey

5. Count of Participants With Procedural Complications

   Time frame: Up to 10 minutes

6. Count of Participants With Side Effects Related to Lidocaine Administration

   Side effects were not necessarily considered to be adverse events by investigator.

   Time frame: Up to 10 minutes

Baseline characteristics

Publications

• 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. PubMed 34352829 ↗

Study documents

• Protocol and statistical analysis plan ↗ · Jul 24, 2018

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — No individual participant data will be shared with other researchers.