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

This study is currently recruiting participants.
Verified June 2013 by Women and Infants Hospital of Rhode Island
Sponsor:
Information provided by (Responsible Party):
Amanda Tower, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01708330
First received: October 11, 2012
Last updated: June 8, 2013
Last verified: June 2013

October 11, 2012
June 8, 2013
October 2012
July 2014   (final data collection date for primary outcome measure)
Pain during intracervical block [ Time Frame: immediate ] [ Designated as safety issue: No ]
Pain on visual analogue scale
Pain during intracervical block [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Pain on visual analogue scale
Complete list of historical versions of study NCT01708330 on ClinicalTrials.gov Archive Site
  • 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
  • Pain during tenaculum placement [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Pain on visual analogue scale
  • Pain during cervical dilation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Pain on visual analogue scale
  • Pain during aspiration [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Pain on visual analogue scale
Complications [ Time Frame: 1 hour after procedure ] [ Designated as safety issue: Yes ]
Complications [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
 
The Effect of Topical Lidocaine on Pain Scores During Manual Vacuum Aspiration for Nonviable Pregnancies
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Nonviable Pregnancy
  • Drug: Lidocaine
    2% Lidocaine gel
  • Drug: Placebo gel
    odorless, colorless gel will be used as a placebo
    Other Name: KY Jelly
  • Placebo Comparator: Placebo gel
    Placebo gel applied topically to the cervix
    Intervention: Drug: Placebo gel
  • Experimental: Lidocaine gel
    2% lidocaine gel applied topically to the cervix
    Intervention: Drug: Lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Amanda Tower, MD 4012741122 atower@wihri.org
Contact: Roxanne Vrees, MD 4012741122 rvrees@wihri.org
United States
 
NCT01708330
12-0039
No
Amanda Tower, Women and Infants Hospital of Rhode Island
Women and Infants Hospital of Rhode Island
Not Provided
Not Provided
Women and Infants Hospital of Rhode Island
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP