Clinical trial NCT01094366: Paracervical Block for Pain Control in First Trimester Abortion
Official title: An Evaluation of the Paracervical Block for Pain Control in First Trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Legal Abortion With Complication
Pain
Keywords: Paracervical Block
pain control
abortion
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation of America
First posted: 2010-03-26
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Pain reported with cervical dilation
timeFrame: 1 Year
Secondary outcomes:
measure: Anticipated and reported pain at various time points
timeFrame: 1 Year
measure: Anxiety reported with the pain expected during the procedure and the procedure itself.
timeFrame: 1 Year
measure: Satisfaction reported with pain control and overall procedure
timeFrame: 1 Year
measure: Need for additional intraoperative and/or postoperative pain medication
timeFrame: 1 Year
Other outcomes:
Locations:
city: Portland
country: United States
facility: Planned Parenthood Columbia Willamette
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Regina M Renner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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