Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bridgeport Hospital
Sponsor:
Collaborator:
Women and Infants Hospital of Rhode Island
Information provided by (Responsible Party):
Amanda Tower, Bridgeport Hospital
ClinicalTrials.gov Identifier:
NCT01708330
First received: October 11, 2012
Last updated: October 24, 2014
Last verified: October 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bridgeport Hospital:

Primary Outcome Measures:
  • Pain during intracervical block [ Time Frame: immediate ] [ Designated as safety issue: No ]
    Pain on visual analogue scale


Secondary Outcome Measures:
  • Pain during tenaculum placement [ Time Frame: immediate ] [ Designated as safety issue: No ]
    Pain on visual analogue scale

  • Pain during cervical dilation [ Time Frame: immediate ] [ Designated as safety issue: No ]
    Pain on visual analogue scale

  • Pain during uterine aspiration [ Time Frame: immediate ] [ Designated as safety issue: No ]
    Pain on visual analogue scale


Other Outcome Measures:
  • Complications [ Time Frame: 1 hour after procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: October 2012
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708330

Contacts
Contact: Amanda Tower, MD 2033844870 amandatowermd@gmail.com
Contact: Roxanne Vrees, MD 4012741122 rvrees@wihri.org

Locations
United States, Rhode Island
Women and Infants Hospital Triage Recruiting
Providence, Rhode Island, United States, 02905
Contact: Roxanne Vrees, MD    401-274-1122    rvrees@wihri.org   
Sponsors and Collaborators
Bridgeport Hospital
Women and Infants Hospital of Rhode Island
  More Information

No publications provided

Responsible Party: Amanda Tower, Fellow, Bridgeport Hospital
ClinicalTrials.gov Identifier: NCT01708330     History of Changes
Other Study ID Numbers: 12-0039
Study First Received: October 11, 2012
Last Updated: October 24, 2014
Health Authority: United States: Women and Infants Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014