Investigating Pre-Procedural Anxiety and Effect of Analgesia on Intrauterine Device Placement and Endometrial Biopsy

The University of Texas System (UT)

Status and phase: Not yet enrolling; Phase 2

Conditions: Anxiety; Pain

Treatments: Drug: Paracervical block- Lidocaine without epinephrine; Drug: Hydroxyzine Hydrochloride; Drug: Benzocaine Gel applied to the cervix

Study type: Interventional

Funder types: Other

Identifiers

NCT07031206

HSC-MS-25-0136

Details and patient eligibility

About

The purpose of this study is to evaluate pre-procedural anxiety and patient pain perception with IUD insertion/ EMB procedure when using analgesia versus no analgesia by the end of the study and to evaluate the effect of age, race, parity, type of IUD and anxiety on pain and to offer better pain management in our patient population, undergoing IUD insertion/EMB procedure at the end of our study.

Enrollment: 152 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• present for an IUD insertion procedure and/or for EMB procedure.

Exclusion criteria

• current Pelvic inflammatory disease (PID)
• contraindications to IUD or EMB
• malignancy
• contraindication to hydroxyzine/Lidocaine/Benzocaine
• positive pregnancy test

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 3 patient groups

Paracervical block- Lidocaine without epinephrine with Hydroxyzine hydrochloride if needed

Experimental group

Treatment:

Drug: Hydroxyzine Hydrochloride

Drug: Paracervical block- Lidocaine without epinephrine

Benzocaine Gel applied to the cervix with Hydroxyzine hydrochloride if needed

Experimental group

Treatment:

Drug: Benzocaine Gel applied to the cervix

Drug: Hydroxyzine Hydrochloride

No analgesia with Hydroxyzine hydrochloride if needed

Experimental group

Treatment:

Drug: Hydroxyzine Hydrochloride