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Paracervical Block for Pain Associated With Laminaria Insertion

Not Applicable
Completed
Conditions
Pain
Interventions
Drug: Sham paracervical block
Registration Number
NCT02454296
Lead Sponsor
University of Hawaii
Brief Summary

To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.

Detailed Description

Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
41
Inclusion Criteria
  • Pregnant women between the ages of 18-49 years
  • Desiring surgical termination of pregnancy or surgical management of a fetal demise
  • Treatment plan involves cervical preparation with laminaria
  • Participant able to provide informed consent in English and willing to participate in the study
Exclusion Criteria
  • Unable to read/speak/understand English
  • Contraindications to receiving lidocaine

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Paracervical Block with lidocaineParacervical Block with lidocaineA paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Sham paracervical blockSham paracervical blockA sham block will be done prior to the placement of laminaria using a capped needle
Primary Outcome Measures
NameTimeMethod
Pain After Placement of Laminaria (100 mm Visual Analog Scale)Measured within 10 seconds after placement of laminaria

We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.

Secondary Outcome Measures
NameTimeMethod
Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)15 minutes post-operatively

Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied

Paracervical or Sham Block PainWithin 10 seconds after receiving paracervical or sham block

Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.

Trial Locations

Locations (1)

University Women's Health Specialists

🇺🇸

Honolulu, Hawaii, United States

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