Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
Information source: Sheba Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain Alleviation; Dilatation and Evacuation; Laminaria Placement
Intervention: Lidocaine (Drug); placebo comparator (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Sheba Medical Center Overall contact:
Avi Shina, MD, Phone: 97235302770, Email: avishina@yahoo.com
Summary
To examine whether application of lidocaine spray in cervical preparation for second
trimester dilatation and evacuation alleviates pain and is superior to current protocol of
preparation without analgesia and superior to placebo.
Methods A prospective randomized placebo controlled trial consisting of three groups
1. Lidocaine spray group (group 1)
2. Placebo group (saline spray) (group 2)
3. No intervention group (as currently in our protocol) (group 3)
- Women undergoing dilatation and Evacuation in the second trimester and are about
to go cervical dilation with osmotic dilators(laminaria) will be invited to
participate in the randomized placebo control trial comparing lidocaine spray,
placebo (saline) or no application (as current protocol).
- Informed consent will be obtained from each participant
- After enrollment patient will be randomized into one of the three study arms by a
computer program
- The patient will be placed in the lithotomy position and the cervix will be
exposed using a sterile bivalve speculum.
- Pain will be assessed in 3 places using a visual analog pain scale 10(no pain) to
100 (worst possible pain).
0 after removal 15
- Group1 :after speculum insertion 4 puffs (40mg) of spray will be applied to the
cervix and after a 2 minute wait laminaria will be inserted.
- Clinical data will be collected including age, parity, general health, Obstetric
and gynecologic history.
- Primary outcome : difference in pain score immediately after speculum removal and
10 minutes after speculum removal
- The protocol will not be repeated if a participant is to return for further
laminaria insertion.
Sample size A sample size was calculated assuming a target difference of 10 (smallest effect
of clinical importance) between the baseline and post laminaria pain score at 15 minutes.
Standard deviation was assumed to be 18 based on similar power. Assuming 80% power and a P
value of 0. 05 sample size of each group was calculated to be 51(5) and hence sample size of
55 was determined .
Participants
- Females aged 16 years and older about to undergo DE Inclusion criteria
- Informed consent
- Women with a fetus Crown rump length (CRL) greater than 10 weeks via ultrasound.
Exclusion criteria
- CRL < 10 weeks
- Clinical Uterine size >22 weeks
- Fetus Bi Parietal Diameter > 50 mm
- Known amide allergy Withdrawal criteria
- Immediate adverse reaction to amides
Clinical Details
Official title: Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Does application of lidocaine to the cervix alleviate pain relative to placebo when inserting laminaria for cervical preparation prior to DE
Eligibility
Minimum age: 16 Years.
Maximum age: 55 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- • Informed consent
- Women with a fetus Crown rump length (CRL) greater than 10 weeks via ultrasound
Exclusion Criteria:
- • CRL <10 weeks
- Clinical Uterine size >22 weeks
- Fetus Bi Parietal Diameter > 50 mm
- Known amide allergy
Locations and Contacts
Avi Shina, MD, Phone: 97235302770, Email: avishina@yahoo.com
Sheba Medical Center, Ramat Gan, Israel; Not yet recruiting
Avi Shina, MD, Phone: 97235302770, Email: avishina@yahoo.com
Avi Shina, MD, Principal Investigator
Additional Information
Last updated: March 25, 2014
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