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The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01708330
First Posted: October 16, 2012
Last Update Posted: July 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Amanda Tower, Bridgeport Hospital
  Purpose

When a patient requires a manual vacuum aspiration (MVA), whether for an undesired pregnancy, missed abortion, or other nonviable pregnancy, she is undergoing an emotional experience. She is grieving the loss of her pregnancy, and is then faced with the anxiety of an invasive and often painful procedure. Minimizing the pain during this procedure must not be overlooked. There have been no randomized controlled trials evaluating pain control during MVA for nonviable pregnancy, and the data is mixed regarding analgesia for MVA for an elective abortion or other office procedures.

Women being treated at the Women & Infants Triage who have experienced a first trimester missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy and are being treated with an outpatient manual vacuum aspiration will be asked to enroll in this study. Those who wish to participate will be randomly assigned to treatment with lidocaine gel or a placebo gel applied to the cervix during their procedure.

The hypothesis is that topical lidocaine will decrease pain during manual vacuum aspiration.


Condition Intervention Phase
Nonviable Pregnancy Drug: Lidocaine Drug: Placebo gel Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Amanda Tower, Bridgeport Hospital:

Primary Outcome Measures:
  • Pain during intracervical block [ Time Frame: immediate ]
    Pain on visual analogue scale


Secondary Outcome Measures:
  • Pain during tenaculum placement [ Time Frame: immediate ]
    Pain on visual analogue scale

  • Pain during cervical dilation [ Time Frame: immediate ]
    Pain on visual analogue scale

  • Pain during uterine aspiration [ Time Frame: immediate ]
    Pain on visual analogue scale


Other Outcome Measures:
  • Complications [ Time Frame: 1 hour after procedure ]

Enrollment: 70
Study Start Date: October 2012
Study Completion Date: July 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo gel
Placebo gel applied topically to the cervix
Drug: Placebo gel
odorless, colorless gel will be used as a placebo
Other Name: KY Jelly
Experimental: Lidocaine gel
2% lidocaine gel applied topically to the cervix
Drug: Lidocaine
2% Lidocaine gel

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient at the Women and Infants Triage/Women's Emergency Department
  • Vital signs are stable
  • Ages 18 and older
  • Have a missed abortion, inevitable abortion, incomplete abortion or other nonviable pregnancy
  • Estimated gestational age up to 10 weeks
  • Undergoing MVA at the Women and Infants Triage/Women's Emergency Department
  • Able to read English or Spanish
  • Able to give informed consent for involvement in the study

Exclusion Criteria:

  • Allergic to lidocaine, iodine or betadine
  • Known sensitivity to any component of the lidocaine or placebo gel.
  • In acute distress
  • Unable to give informed consent
  • Unable to read English or Spanish
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708330


Locations
United States, Rhode Island
Women and Infants Hospital Triage
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Bridgeport Hospital
Women and Infants Hospital of Rhode Island
  More Information

Responsible Party: Amanda Tower, Fellow, Bridgeport Hospital
ClinicalTrials.gov Identifier: NCT01708330     History of Changes
Other Study ID Numbers: 12-0039
First Submitted: October 11, 2012
First Posted: October 16, 2012
Last Update Posted: July 20, 2016
Last Verified: July 2016

Keywords provided by Amanda Tower, Bridgeport Hospital:
manual vacuum aspiration
missed abortion
incomplete abortion
nonviable pregnancy
topical lidocaine

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action