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OpenTrials
Completed

NCT Number: NCT02454296

Paracervical Block for Pain Associated With Laminaria Insertion

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Women's Health Specialists

Honolulu, Hawaii, 96826, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracervical Block with lidocaine

Drug

Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion

Other names: Paracervical block

Sham paracervical block

Drug

A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes

Other names: Sham block; placebo

Primary outcomes

  1. Pain After Placement of Laminaria (100 mm Visual Analog Scale)

    Time frame: 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 outcomes

  1. Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)

    Time frame: 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

  2. Paracervical or Sham Block Pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 27, 2015
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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