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Completed

NCT Number: NCT01094366

Paracervical Block for Pain Control in First Trimester Abortion

Many woman undergoing a surgical abortion receive a paracervical nerve block for pain reduction, in which lidocaine (a numbing medication) is injected around the cervix. These injections numb the cervix and possibly the lower part of the uterus. However, the injection can be uncomfortable and it is not well known whether it is effective in reducing pain. The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that paracervical block might have on that pain.

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Key information

Conditions

Legal Abortion With Complication Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Planned Parenthood Columbia Willamette

Portland, Oregon, 97212, United States

About this study

The investigators expect to have 120 women complete this study, between study sites at OHSU's Center for Women's Health and Planned Parenthood Columbia Willamette in Portland, OR. Every participant will still receive the standard oral medication for pain (ibuprofen) and anxiety (lorazepam). Eligible subjects will be at least 18 years of age, less than 11 weeks pregnant and have already decided to have a surgical abortion.

The primary outcome evaluated will be pain reported at time of cervical dilation. The investigators will assess pain at various time points (including secondary outcomes) immediately upon completion of the respective step and pain and satisfaction 30 minutes postoperatively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 18 years or older
  • Voluntarily requesting pregnancy termination
  • Ultrasound confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age
  • Good general health
  • English or Spanish speaking
  • Be able and willing to sign an informed consent and agree to terms of the study

Exclusion criteria

  • Gestational ages over 11 0/7 weeks, due to routine misoprostol use at our institutions
  • Incomplete abortion
  • Required or requested narcotics or IV sedation (prior to randomization)
  • Patients who refuse Ibuprofen and paracervical blocks
  • Contraindications or allergies to lidocaine, ibuprofen or ativan
  • Significant physical or mental health condition
  • Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
  • Patients with known hepatic disease
  • Women, who in the opinion of the investigator are not suitable for the study protocol

Treatment and study plan

Paracervical block

Procedure

Subject receives 20 mL paracervical block with 18 mL of 1% Lidocaine solution buffered with 2 mL 8.4% sodium bicarbonate for pain control.

Sham Paracervical Block

Procedure

In the non-intervention group, the surgeon performs a sham PCB during which 2 mL buffered lidocaine solution are injected at the tenaculum site, after which a capped needle gently simulates the standard PCB procedure.

Primary outcomes

  1. Pain reported with cervical dilation

    Time frame: 1 Year

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of cervical dilation.

Secondary outcomes

  1. Anticipated and reported pain at various time points

    Time frame: 1 Year

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of anticipated pain) recorded prior to the procedure.

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of positioning for procedure, speculum insertion, placement of the PCB, aspiration and 30 min postoperatively.

  2. Anxiety reported with the pain expected during the procedure and the procedure itself.

    Time frame: 1 Year

    Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of anxiety) recorded prior to procedure.

  3. Satisfaction reported with pain control and overall procedure

    Time frame: 1 Year

    Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of satisfaction) recorded post procedure.

  4. Need for additional intraoperative and/or postoperative pain medication

    Time frame: 1 Year

    Subjects may request additional pain medication once their procedure has begun or in recovery. The need for additional medication, and what medication was subsequently distributed, will be recorded.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Planned Parenthood Federation of America

Registry information

Official study title

An Evaluation of the Paracervical Block for Pain Control in First Trimester Surgical Abortion

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Mar 26, 2010
Registry last updated
Dec 27, 2019

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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