Tenaculum Pain Control Study

Status Completed

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine injection versus topical lidocaine gel on the pain experienced by patients undergoing tenaculum application to the cervix during office gynecologic procedures. This study will also evaluate how satisfied women are with the method of pain control used.

The researchers hypothesize that:

1. There is less pain perceived by patients undergoing placement of a tenaculum on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.

2. Patients are more satisfied with pain control during the overall experience of undergoing tenaculum placement on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.

Clinical Trial Description

Subjects who have already scheduled an IUD insertion or endometrial biopsy will be asked to join this study assessing two pain control interventions at the time of tenaculum application to the cervix during office gynecologic procedures. Only healthy women ages 18 and over with an indication for endometrial biopsy or IUD placement will be recruited. The participants will be randomized to one of two arms: an intracervical lidocaine injection versus topical lidocaine gel. They will be asked to indicate their level of pain and level of satisfaction using a Visual Analog Scale. The primary outcome, pain with tenaculum placement, and the secondary outcome, satisfaction with the experience of tenaculum placement, will be compared between the study groups. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01421641
Study type	Interventional
Source	Oregon Health and Science University
Contact
Status	Completed
Phase	Phase 4
Start date	September 2011
Completion date	May 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04077801` - Effect Of Chronic Pelvic Pain on Lumbopelvic Alignment And TemproMandibular Joint Kinematics in Women
Completed	`NCT03740932` - Effect of Biomechanical Alignment and Jaw on Women With Pelvic Pain
Completed	`NCT04081532` - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain	N/A
Recruiting	`NCT06101303` - Endometriosis Pain
Recruiting	`NCT03868137` - Multi-dose Ibuprofen Prophylaxis for IUD-insertion	N/A
Suspended	`NCT04069572` - Vibratory Stimulation for the Treatment of Chronic Pain	N/A
Completed	`NCT02923245` - POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound	N/A
Completed	`NCT02547857` - Transvaginal Pelvic Ultrasound in the ED	N/A
Completed	`NCT01938092` - Vaginal Diazepam for the Treatment of Female Pelvic Pain	Phase 2
Active, not recruiting	`NCT01731470` - Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)	N/A
Completed	`NCT00034047` - Endometriosis : Traditional Medicine vs Hormone Therapy	Phase 1/Phase 2
Completed	`NCT05368155` - Chronic Pelvic Pain and Education Skills Training for Women Veterans	N/A
Completed	`NCT04179149` - Enriched Environments in Endometriosis	N/A
Not yet recruiting	`NCT05530681` - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth	N/A
Completed	`NCT04077775` - Temporomandibular Joint Kinematics Changes in Pregnant Women: A Case-control Study
Completed	`NCT03715777` - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain	Phase 3
Recruiting	`NCT05926752` - Photobiomodulation for Myofascial Pelvic Pain	N/A
Completed	`NCT02588885` - Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention	N/A
Completed	`NCT02261740` - Program to Overcome Pelvic Pain With Yoga	N/A
Completed	`NCT02259712` - Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy	N/A