Paracervical Block for Pain Control in First Trimester Abortion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Oregon Health and Science University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Planned Parenthood Federation of America
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01094366
First received: March 25, 2010
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Legal Abortion With Complication
Pain
Procedure: Paracervical Block
Procedure: Sham Paracervical Block
Phase 4

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

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

Primary Outcome Measures:
  • Pain reported with cervical dilation [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of cervical dilation.


Secondary Outcome Measures:
  • Anticipated and reported pain at various time points [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

    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.


  • Anxiety reported with the pain expected during the procedure and the procedure itself. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of anxiety) recorded prior to procedure.

  • Satisfaction reported with pain control and overall procedure [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of satisfaction) recorded post procedure.

  • Need for additional intraoperative and/or postoperative pain medication [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: June 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: No Paracervical Block for Pain Control
Subject will not receive a paracervical block during the procedure
Procedure: Sham Paracervical Block
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.
Active Comparator: Paracervical Block for Pain Control
Subject will receive a paracervical block during the procedure.
Procedure: Paracervical Block
Subject receives 20 mL paracervical block with 18 mL of 1% Lidocaine solution buffered with 2 mL 8.4% sodium bicarbonate for pain control.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094366

Locations
United States, Oregon
Planned Parenthood Columbia Willamette
Portland, Oregon, United States, 97212
Sponsors and Collaborators
Oregon Health and Science University
Planned Parenthood Federation of America
Investigators
Principal Investigator: Regina M Renner, MD Oregon Health and Science University
  More Information

Publications:
Donati, S., Medda, E., Proietti, S., Rizzo, L., Spinelli, A., Subrizi, D., et al. (1996). Reducing pain of first trimester abortion under local anaesthesia. Eur J Obstet Gynecol Reprod Biol, 70(2), 145-149.
Nichols, M. D., Halvorson-Boyd, G., Goldstein, R., Gevirtz, C., & Healow, D. (2009). Pain management. In M. Paul, E. S. Lichtenberg, L. Borgatta, D. A. Grimes & P. G. Stubblefield (Eds.), Management of unintended and abnormal pregnancy. (pp. 90-110): Wiley-Blackwell.
Rabin, J. M., Spitzer, M., Dwyer, A. T., & Kaiser, I. H. (1989). Topical anesthesia for gynecologic procedures. Obstet Gynecol, 73(6), 1040-1044.
trauss, L. T., Gamble, S. B., Parker, W. Y., Cook, D. A., Zane, S. B., & Hamdan, S. (2007). Abortion surveillance--United States, 2004. MMWR Surveill Summ, 56(9), 1-33.
Wiebe, E. R., & Rawling, M. (1995). Pain control in abortion. Int J Gynaecol Obstet, 50(1), 41-46.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regina Maria Renner, MD, Oregon Health and Sciences University
ClinicalTrials.gov Identifier: NCT01094366     History of Changes
Other Study ID Numbers: OHSU IRB 6071
Study First Received: March 25, 2010
Last Updated: March 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Paracervical Block
pain control
abortion

ClinicalTrials.gov processed this record on April 17, 2014