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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

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.


Detailed Summary:
Sponsor: Bridgeport Hospital

Current Primary Outcome: Pain during intracervical block [ Time Frame: immediate ]

Pain on visual analogue scale


Original Primary Outcome: Pain during intracervical block [ Time Frame: 1 hour ]

Pain on visual analogue scale


Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • Pain during tenaculum placement [ Time Frame: 1 hour ]
    Pain on visual analogue scale
  • Pain during cervical dilation [ Time Frame: 1 hour ]
    Pain on visual analogue scale
  • Pain during aspiration [ Time Frame: 1 hour ]
    Pain on visual analogue scale


Information By: Bridgeport Hospital

Dates:
Date Received: October 11, 2012
Date Started: October 2012
Date Completion:
Last Updated: July 18, 2016
Last Verified: July 2016