Clinical trial NCT02454296: Paracervical Block for Pain Associated With Laminaria Insertion
Official title: Paracervical Block for Pain Associated With Laminaria Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Laminaria
Lead sponsor: University of Hawaii
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain After Placement of Laminaria (100 mm Visual Analog Scale)
timeFrame: Measured within 10 seconds after placement of laminaria
Secondary outcomes:
measure: Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)
timeFrame: 15 minutes post-operatively
measure: Paracervical or Sham Block Pain
timeFrame: Within 10 seconds after receiving paracervical or sham block
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: University Women's Health Specialists
state: Hawaii
Study officials:
affiliation: University of Hawaii
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
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