Health TrialsbyHealthPanel

Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement

ConditionsPain ManagementAbortionSecond Trimester AbortionDilation and Evacuation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRush University Medical Center

About this trial

The purpose of this study is to improve pain management for participantswho need osmotic dilators for cervical preparation the day before their second trimester abortion procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketorolac

    Drug

    Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement. Immediately prior to placement of osmotic dilators, a 1% lidocaine + ketorolac paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL ketorolac (30mg) will be administered.

  • oral ibuprofen

    Drug

    Subjects in the control group will take oral ibuprofen 600mg 30-60 minutes prior to osmotic dilator placement.

  • Placebo

    Drug

    Subjects in the treatment group will take oral placebo 30-60 minutes prior to osmotic dilator placement.

  • Lidocaine HCl 1%

    Drug

    Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed in the following fashion: Two milliliters of the analgesic mixture will be placed at the tenaculum site intracervically. After the tenaculum is placed, the remaining 18 mL of the analgesic mixture will be administered at 4 and 8 o'clock at the cervicovaginal reflection.

  • Saline

    Drug

    Immediately prior to placement of osmotic dilators, a 1% lidocaine paracervical block (containing 18 mL of 1% lidocaine combined with 2 mL of saline) will be performed.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Intervention Treatment GroupExperimental treatment 3 interventions
Group B: Standard TreatmentActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Pain post-osmotic dilator insertion

i. Mean difference between arms in NRS immediately after insertion of osmotic dilators

Time frame
After placement of last osmotic dilator, and prior to insertion of gauze and speculum removal

Secondary outcomes

1

Pain with maintenance of osmotic dilators

Mean difference between arms in NRS at 5 minutes (in clinic), 30 minutes and 1, 2, 4, 6 hours (all by text-message) after insertion of osmotic dilators.

Time frame
5 minutes to 6 hours after insertion of osmotic dilators
2

Patient Satisfaction

Mean difference in satisfaction measured with 100mm VAS.

Time frame
5 minutes after insertion of osmotic dilators
3

Cervical dilators (exploratory)

Cervical dilation assessed with digital exam after removal of osmotic dilators at time of D\&E; mechanical dilation performed during D\&E (yes/no)

Time frame
Intraoperatively at start of D&E

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now