Paracervical Block for Pain Control in First Trimester Abortion

Phase 4

Completed

• Conditions: Legal Abortion With Complication; Pain
• Interventions: Procedure: Sham Paracervical Block; Procedure: Paracervical Block

• Registration Number: NCT01094366
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Study Start: 2010-04
• Primary Completion: 2010-10
• Study Completion: 2012-11
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-24
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Paracervical Block for Pain Control	Sham Paracervical Block	Subject will not receive a paracervical block during the procedure
Paracervical Block for Pain Control	Paracervical Block	Subject will receive a paracervical block during the procedure.

Primary Outcome Measures

Name	Time	Method
Pain reported with cervical dilation	1 Year	Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of cervical dilation.

Secondary Outcome Measures

Name	Time	Method
Anxiety reported with the pain expected during the procedure and the procedure itself.	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	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	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.
Anticipated and reported pain at various time points	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.

Trial Locations

Locations (1)

Planned Parenthood Columbia Willamette; 🇺🇸 Portland, Oregon, United States