Paracervical Block During Office Hysteroscopy

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 2

Conditions: Paracervical Block

Treatments: Drug: Normal Saline; Drug: Lidocaine paracervical block

Study type: Interventional

Funder types: Other

Identifiers

NCT00811187

06-09-395

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.

Enrollment: 80 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women eligible and scheduled for office hysteroscopic placement of essure devices

Exclusion criteria

• Planned secondary procedures
• Lidocaine allergy
• Repeat procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

Lidocaine paracervical block

Experimental group

Description:

5cc 1% lidocaine injection in each paracervical region

Treatment:

Drug: Lidocaine paracervical block

Saline placebo injection

Placebo Comparator group

Description:

5cc Normal Saline injection in each paracervical region

Treatment:

Drug: Normal Saline