NCT02454296

Paracervical Block for Pain Associated With Laminaria Insertion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Hawaii · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.

Detailed description

Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Paracervical Block with lidocaine	Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
DRUG	Sham paracervical block	A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-05-27
• Last updated: 2017-04-14
• Results posted: 2017-04-14

Locations

1 site across 1 country: United States