Clinical trial NCT01466491: Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
Official title: Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Pain during first-trimester surgical abortion
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation of America
First posted: 2011-11-08
Enrollment: 332
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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:

1. Socio-demographic and clinical data: age, race, gravidity, parity, gestational age, prior vaginal delivery, prior abortion, level of menstrual symptoms
2. 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

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
* 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

Primary outcomes:
measure: Patient Perception of Pain
timeFrame: after completion of cervical dilation
Secondary outcomes:
measure: Pain Scores Throughout Procedure at Various Time Points
timeFrame: up to several hours
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Portland
country: United States
facility: Planned Parenthood Columbia Willamette
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Paula Bednarek, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: