Paracervical Block for Pain Control in First Trimester Abortion
|ClinicalTrials.gov Identifier: NCT01094366|
Recruitment Status : Unknown
Verified March 2011 by Oregon Health and Science University.
Recruitment status was: Active, not recruiting
First Posted : March 26, 2010
Last Update Posted : March 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Legal Abortion With Complication Pain||Procedure: Paracervical Block Procedure: Sham Paracervical Block||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Evaluation of the Paracervical Block for Pain Control in First Trimester Surgical Abortion|
|Study Start Date :||April 2010|
|Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||June 2011|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094366
|United States, Oregon|
|Planned Parenthood Columbia Willamette|
|Portland, Oregon, United States, 97212|
|Principal Investigator:||Regina M Renner, MD||Oregon Health and Science University|