Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion

Oregon Health & Science University (OHSU)

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Drug: Paracervical block technique with lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01466491

OHSU SFP 7688

Details and patient eligibility

About

The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that varying paracervical block techniques might have on that pain. These different techniques involve wait time following the injection as well as the number of sites injected.

Full description

The investigators plan to conduct a single-blinded randomized trial of 350 women undergoing elective first-trimester surgical abortion. Subjects will be randomized to two different paracervical block techniques, but both the medications and the amount of medications will remain the same. Subjects will not know to which group they have been randomized as this knowledge may affect how much pain is felt.

Primary Outcome:

Patient reported pain with cervical dilation during first trimester surgical abortion. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation. The 100-mm VAS scale is a well established and validated study instrument.

Secondary Outcomes:

Socio-demographic and clinical data: age, race, gravidity, parity, gestational age, prior vaginal delivery, prior abortion, level of menstrual symptoms

Pain (VAS scale):

anticipated baseline with speculum insertion with placement of the PCB with aspiration 30 min postoperatively intrapersonal pain changes (calculated in analysis) anxiety [baseline] (VAS scale; anchors 0 = none, 100mm = worst imaginable): of pain of surgery satisfaction (VAS scale; anchors 0 = not, 100mm = very satisfied): with pain control overall abortion experience adverse events need for additional intraoperative and/or postoperative pain medication participants' belief if they were in the intervention or control group

Enrollment

332 patients

Sex

Female

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

age 18 years or older
voluntarily requesting pregnancy termination
ultrasound-confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age
generally healthy
English or Spanish speaking
able or willing to sign an informed consent and agree to terms of the study

Exclusion criteria

gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this gestational age at the study sites)
incomplete abortion
failed medical abortion
required or requested IV sedation (prior to randomization)
patient who declines Ibuprofen, Lorazepam or PCB
medical contraindication or allergy to any of the study medications
chronic use of narcotic pain medication or heroin
significant physical or mental health condition
adnexal mass or tenderness on pelvic exam consistent with inflammatory disease
known hepatic disease
women who, in the opinion of the investigator, are not suitable for the study protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

332 participants in 4 patient groups, including a placebo group

4-site injection

Placebo Comparator group

Description:

The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).

Treatment:

Drug: Paracervical block technique with lidocaine

2-site Injection

Active Comparator group

Description:

The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).

Treatment:

Drug: Paracervical block technique with lidocaine

4-Site PCB followed by 3-minute wait

Placebo Comparator group

Description:

Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation

Treatment:

Drug: Paracervical block technique with lidocaine

4-site PCB followed by no wait

Active Comparator group

Description:

Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).