Abortion, Induced, Pain
Conditions
Keywords
Local anesthesia, Paracervical, Intracervical, Abortion, Pain, Local anesthesia for elective first trimester abortion
Brief summary
The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.
Interventions
PROCEDUREParacervical block
The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.
PROCEDUREIntracervical
The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.
DRUGBuffered Lidocaine, vasopressin, sodium bicarbonate
The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women presenting for elective first trimester abortion
Exclusion criteria
* Gestation over 12 weeks by ultrasound * Weight less than 98 pounds * Known allergy to lidocaine * Known nonviable pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS) | at completion of procedure | VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain |
Secondary
| Measure | Time frame |
|---|---|
| Gestational Age at Time of Procedure | At the time of the procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paracervical Block All patients who met inclusion criteria were approached for the study. Exclusion criteria included gestational age greater than 12 weeks, patient age less than 18, patient weight less than 44 kg, patient allergy to any component of the local anesthetic, patient need for general anesthesia, inability to understand the consent form, nonviable pregnancy, current incarceration. | 45 |
| Intracervical Block All patients who met inclusion criteria were approached for the study. Exclusion criteria included gestational age greater than 12 weeks, patient age less than 18, patient weight less than 44 kg, patient allergy to any component of the local anesthetic, patient need for general anesthesia, inability to understand the consent form, nonviable pregnancy, current incarceration. | 44 |
| Total | 89 |
Baseline characteristics
| Characteristic | Paracervical Block | Intracervical Block | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 44 Participants | 89 Participants |
| Sex: Female, Male Female | 45 Participants | 44 Participants | 89 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 44 |
| other Total, other adverse events | 0 / 45 | 0 / 44 |
| serious Total, serious adverse events | 0 / 45 | 0 / 44 |
Outcome results
Primary
Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)
VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain
Time frame: at completion of procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracervical Block | Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS) | 4.25 units on a scale | Standard Deviation 0.6 |
| Intracervical Block | Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS) | 3.97 units on a scale | Standard Deviation 0.5 |
Secondary
Gestational Age at Time of Procedure
Time frame: At the time of the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracervical Block | Gestational Age at Time of Procedure | 51 Days | Standard Deviation 11 |
| Intracervical Block | Gestational Age at Time of Procedure | 54 Days | Standard Deviation 9 |