Please select the eligibility criteria that correspond to the clinical trial below.
Title: Self-Administered Lidocaine Gel for Pain Management With First Trimester Surgical Abortion: A Randomized Controlled Trial
Brief Summary: Despite global efforts to decrease discomfort during surgical abortion, pain remains a limiting factor in where and how procedures are performed. Several studies have investigated different methods of delivering cervical anesthesia prior to abortion, however to the best of the investigators' knowledge, there is no published data that 1) rigorously examines the effect of a time interval between local anesthetic administration and procedure initiation, or 2) explores whether adequate pain relief is possible through self-administered, non-invasive means alone. Research in this area has a significant public health impact, given the large number of women worldwide who seek abortions.

The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the traditional paracervical block prior to first trimester surgical abortion. They hypothesize that lidocaine gel is no worse than paracervical block at decreasing abortion related pain at a variety of time points throughout the procedure. This is a non-inferiority, open label, randomized controlled trial.

If self-administered vaginal gel is acceptable and effective, it would increase options for pain control during abortion and other gynecologic procedures.


Options:
A: Inclusion criteria:

* Women ages 18 and older undergoing elective surgical abortion at 5 and 0/7 to 11 and 6/7 weeks gestational age
* Use of IV sedation for pain management
* English or Spanish speaking
* Ability to give informed consent

Exclusion criteria:

* Any pre-operative use of misoprostol (typically given at 12 weeks and above in this clinic)
* Allergy to study medications: lidocaine, midazolam, fentanyl
* Known uterine anomaly
* Prior cervical surgery.
B: Inclusion Criteria:

* Age 18 or older.
* Undesired pregnancy between 6 0/7-12 6/7 weeks gestation.
* Has already signed consent for pregnancy termination.
* Eligible for IV sedation per clinic protocol.

Exclusion Criteria:

* Under 120 lbs.
* Allergies to any of the drugs being studied.
* Chronic narcotics, barbiturates or benzodiazepine use within the past year.
* History of IV drug use within the last year.
* Inability to give informed consent.
* Does not speak English or Spanish and does not have translator for all study procedures
* Previously participated in study
C: 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
D: Inclusion Criteria:

* Aged 18 years or older
* Voluntarily requesting surgical pregnancy termination
* Pregnancy with intrauterine gestational sac up to 10 weeks 6 days gestation, dated by ultrasound
* Eligible for suction curettage
* English or Spanish speaking
* Good general health
* Able and willing to give informed consent and agree to terms of the study

Exclusion Criteria:

* Gestational ages 11 weeks or more
* Incomplete abortion
* Premedication with misoprostol
* Use of any opioid medication within the past 7 days
* Use of heroin within the past 7 days
* Requested opioids or IV sedation prior to start of the procedure
* Patients who refuse ibuprofen or lorazepam
* Contraindications or allergies to HC/APAP, lidocaine, ibuprofen, or lorazepam
* Significant medical problem necessitating inpatient procedure
* Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
* Known hepatic disease

Answer: A