This trial is active, not recruiting.

Conditions legal abortion with complication, pain
Treatments paracervical block, sham paracervical block
Phase phase 4
Sponsor Oregon Health and Science University
Collaborator Planned Parenthood Federation of America
Start date April 2010
End date October 2010
Trial size 120 participants
Trial identifier NCT01094366, OHSU IRB 6071


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose diagnostic
(Sham Comparator)
Subject will not receive a paracervical block during the 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)
Subject will receive a paracervical block during the 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.

Primary Outcomes

Pain reported with cervical dilation
time frame: 1 Year

Secondary Outcomes

Anticipated and reported pain at various time points
time frame: 1 Year
Anxiety reported with the pain expected during the procedure and the procedure itself.
time frame: 1 Year
Satisfaction reported with pain control and overall procedure
time frame: 1 Year
Need for additional intraoperative and/or postoperative pain medication
time frame: 1 Year

Eligibility Criteria

Female participants from 18 years up to 60 years old.

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

Additional Information

Official title An Evaluation of the Paracervical Block for Pain Control in First Trimester Surgical Abortion
Principal investigator Regina M Renner, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.