Paracervical Block in First Trimester Surgical Abortions

August 17, 2017 updated by: Johns Hopkins University

Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions

The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone.

This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS.

The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Planned Parenthood Columbia-Willamette

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age greater than or equal to 18 years
  • English-speaking
  • ability and willingness to sign the informed consent
  • ability and willingness to comply with the terms of the study
  • voluntary request for pregnancy termination
  • ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age not exceeding 76 days (10 6/7 weeks) from the first day of the preceding menstrual cycle

Exclusion Criteria:

  • women who require or request sedation
  • untreated acute cervicitis or pelvic inflammatory disease
  • contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria
  • allergic reaction or sensitivity to lorazepam or NSAIDs
  • chronic NSAID use
  • history of gastritis or gastric ulcer
  • acute renal failure or chronic renal disease
  • chronic liver disease
  • history of bleeding diathesis
  • chronic narcotic use
  • current or past history of illegal drug use (excluding marijuana)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: paracervical block with lidocaine
Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
Drug: lidocaine
paracervical block with lidocaine
Experimental: paracervical block with ketorolac and lidocaine
Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
Drug: ketorolac and lidocaine
paracervical block with ketorolac and lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
Time Frame: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure

100-mm Visual Analogue Scale (VAS) during specific time intervals of D&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain)

Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure.
Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale Regarding Satisfaction Level
Time Frame: end of study (prior to clinic discharge)
100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)
end of study (prior to clinic discharge)
Reported Symptoms
Time Frame: end of study (upon discharge from facility after procedure)
fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)
end of study (upon discharge from facility after procedure)
Complications
Time Frame: end of study
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Oregon Health and Science University

Investigators

  • Principal Investigator: Johns Hopkins University, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

February 4, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00013075
  • SFP1-1 (Other Grant/Funding Number: Society of Family Planning)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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