Paracervical Block for Pain Associated With Laminaria Insertion
- 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
- 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
- Unable to read/speak/understand English
- Contraindications to receiving lidocaine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paracervical Block with lidocaine Paracervical Block with lidocaine A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate. Sham paracervical block Sham paracervical block A sham block will be done prior to the placement of laminaria using a capped needle
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Pain Within 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