Intracervical Block Versus Placebo to Assess Pain Control During Hysterosalpingogram

This study has been completed.
Sponsor:
Information provided by:
Wilford Hall Medical Center
ClinicalTrials.gov Identifier:
NCT00372658
First received: September 5, 2006
Last updated: September 6, 2006
Last verified: December 2005
  Purpose

The purpose of this study is to compare the efficacy of 1% lidocaine intracervical block to placebo for pain control during the performance of a hysterosalpingogram (HSG). We hypothesized that an intracervical block would decrease pain during a hysterosalpingogram.


Condition Intervention Phase
Infertility
Drug: 1% Lidocaine intracervical injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Intracervical Block and Pain Perception During the Performance of a Hysterosalpingogram: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:
  • Visual analogue and qualitative scales to assess study participants pain at 6 different time points during the hysterosalpingogram.

Secondary Outcome Measures:
  • Anatomical result of the hysterosalpingogram were also collected for a sub-group analysis to evaluate if particular pathology had an effect on pain scores.

Estimated Enrollment: 120
Study Start Date: July 2002
Estimated Study Completion Date: October 2004
Detailed Description:

The hysterosalpingogram (HSG) is an integral part of the evaluation for anatomic etiologies of female infertility. The majority of women regard a hysterosalpingogram as acutely painful since it involves placement of a cervical tenaculum, traction on the cervix, and instillation of dye through a cervical cannula. Different techniques have been employed to attempt to make the procedure less painful, including use of balloon catheters rather than cannulas; however, this has not been shown to be uniformly effective. Previous studies have shown a reduction in overall pain during HSG after pre-medication with oral non-steroidal anti-inflammatory drugs. Benzocaine gel (20%) applied to the cervix has also been shown to reduce pain. Conversely, a study of pre-medication with paracetamol (acetaminophen) showed no statistical improvement in pain perception. Additionally, transcervical intrauterine instillation of lidocaine has been shown in randomized studies to not improve pain scores and may actually increase pain after the procedure is complete A MEDLINE literature search of papers written in English from January 1966 to August 2005, using the keywords “hysterosalpingogram,” “analgesia”, “paracervical,” and “intracervical” did not reveal any prior studies on the use of an intracervical block prior to hysterosalpingography. A paracervical block has been shown to decrease pain with therapeutic abortions, endometrial biopsy, and office hysteroscopy (7, 8). We hypothesized that an intracervical block would also decrease pain during a hysterosalpingogram. A three armed, randomized controlled trial comparing pain control after a 1% lidocaine intracervical block, saline injection or no injection in patients undergoing hysterosalpingogram was performed.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients without a known cause for their infertility who were undergoing a hysterosalpingogram were eligible for enrollment.
  • All subjects were 18 to 40 years of age and married.

Exclusion Criteria:

  • Included a history of any allergies to local anesthetics, radio-opaque dye or to anti-inflammatory medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372658

Locations
United States, Texas
Wiford Hall Medical Center
Lackland AFB, Texas, United States, 78236
Sponsors and Collaborators
Wilford Hall Medical Center
Investigators
Principal Investigator: Randal D Robinson, MD Wilford Hall Medical Center and Brooke Army Medical Center
  More Information

No publications provided by Wilford Hall Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00372658     History of Changes
Other Study ID Numbers: FWH20010125H
Study First Received: September 5, 2006
Last Updated: September 6, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Wilford Hall Medical Center:
hysterosalpingogram
intracervical local anesthesia
pain perception
visual analogue scale

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014