Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oregon Health and Science University
Sponsor:
Collaborator:
Planned Parenthood Federation of America
Information provided by (Responsible Party):
Paula Bednarek, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01466491
First received: November 1, 2011
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that varying paracervical block techniques might have on that pain. These different techniques involve wait time following the injection as well as the number of sites injected.


Condition Intervention Phase
Pain
Drug: Paracervical block technique with lidocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Patient Perception of Pain [ Time Frame: At time of uterine aspiration (baseline) ] [ Designated as safety issue: No ]
    To determine whether varying paracervical block techniques affect patient perception of pain. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation.


Secondary Outcome Measures:
  • Anticipated and reported pain at various time points [ Time Frame: One year ] [ Designated as safety issue: No ]

    Distance (mm) from the left of the 100 mm VAS scale (VAS achors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure:

    • prior to medication
    • after receiving medications, just prior to procedure
    • after speculum insertion
    • with placement of PCB
    • with cervical dilation
    • 30 minutes post-operatively
    • intrapersonal pain changes (calculated in analysis)

  • Baseline Anxiety [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 mm=none, 100 mm=worst imagineable) recorded by patient before procedure.

  • Satisfaction with pain control and overall abortion experience [ Time Frame: One Year ] [ Designated as safety issue: No ]
    Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 mm=unsatisfied, 100 mm=very satisfied) recorded 30 minutes post-procedure.


Estimated Enrollment: 350
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 4-site injection
The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Drug: Paracervical block technique with lidocaine
The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
Active Comparator: 2-site Injection
The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).
Drug: Paracervical block technique with lidocaine
The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
Placebo Comparator: 4-Site PCB followed by 3-minute wait
Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Drug: Paracervical block technique with lidocaine
The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
Active Comparator: 4-site PCB followed by no wait
Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Drug: Paracervical block technique with lidocaine
The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.

Detailed Description:

The investigators plan to conduct a single-blinded randomized trial of 350 women undergoing elective first-trimester surgical abortion. Subjects will be randomized to two different paracervical block techniques, but both the medications and the amount of medications will remain the same. Subjects will not know to which group they have been randomized as this knowledge may affect how much pain is felt.

Primary Outcome:

Patient reported pain with cervical dilation during first trimester surgical abortion. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation. The 100-mm VAS scale is a well established and validated study instrument.

Secondary Outcomes:

  1. Socio-demographic and clinical data: age, race, gravidity, parity, gestational age, prior vaginal delivery, prior abortion, level of menstrual symptoms
  2. Pain (VAS scale):

    • anticipated
    • baseline
    • with speculum insertion
    • with placement of the PCB
    • with aspiration
    • 30 min postoperatively
    • intrapersonal pain changes (calculated in analysis)
    • anxiety [baseline] (VAS scale; anchors 0 = none, 100mm = worst imaginable):
    • of pain
    • of surgery
    • satisfaction (VAS scale; anchors 0 = not, 100mm = very satisfied):
    • with pain control
    • overall abortion experience
    • adverse events
    • need for additional intraoperative and/or postoperative pain medication
    • participants' belief if they were in the intervention or control group
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18 years or older
  • voluntarily requesting pregnancy termination
  • ultrasound-confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age
  • generally healthy
  • English or Spanish speaking
  • able or willing to sign an informed consent and agree to terms of the study

Exclusion Criteria:

  • gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this gestational age at the study sites)
  • incomplete abortion
  • failed medical abortion
  • required or requested IV sedation (prior to randomization)
  • patient who declines Ibuprofen, Lorazepam or PCB
  • medical contraindication or allergy to any of the study medications
  • chronic use of narcotic pain medication or heroin
  • significant physical or mental health condition
  • adnexal mass or tenderness on pelvic exam consistent with inflammatory disease
  • known hepatic disease
  • women who, in the opinion of the investigator, are not suitable for the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466491

Contacts
Contact: Joslyn Gibson, BA 503-494-7051 gibsonjo@ohsu.edu
Contact: Matthew John Geraths, MA 503-418-1288 gerathsm@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States
Contact: Paula Bednarek, MD MPH    503-494-8842    bednarek@ohsu.edu   
Principal Investigator: Paula Bednarek, MD MPH         
Planned Parenthood Columbia Willamette Recruiting
Portland, Oregon, United States
Principal Investigator: Paula Bednarek, MD MPH         
Sponsors and Collaborators
Oregon Health and Science University
Planned Parenthood Federation of America
Investigators
Principal Investigator: Paula Bednarek, MD MPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Paula Bednarek, Assistant Professor, Department of Obstetrics and Gynecology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01466491     History of Changes
Other Study ID Numbers: OHSU SFP 7688
Study First Received: November 1, 2011
Last Updated: November 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Pain during first-trimester surgical abortion

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014