CompletedNCT01466491Updated Nov 8, 2019Results posted

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

A Phase 4 interventional study of Paracervical block technique with lidocaine in Pain, sponsored by Oregon Health and Science University. Completed at 2 sites in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-08.

Sponsored by Oregon Health and Science University · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 332
Allocation: Randomized
Ages: 18 Years to 99 Years
Sex: Female

Study 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.

Read the 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:

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

Conditions studied

Pain

Keywords

Pain during first-trimester surgical abortion

In context

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 332 participants (actual)

Study arms

Placebo comparator
4-site injection
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).
Drug: Paracervical block technique with lidocaine
Active comparator
2-site Injection
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).
Drug: Paracervical block technique with lidocaine
Placebo comparator
4-Site PCB followed by 3-minute wait
Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
Drug: Paracervical block technique with lidocaine
Active comparator
4-site PCB followed by no wait
Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Drug: Paracervical block technique with lidocaine

Interventions

DrugParacervical block technique with lidocaine
The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.

What researchers measure

Primary outcomes

Patient Perception of Pain
To determine whether varying paracervical block techniques affect patient perception of pain. 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.
Time frame: after completion of cervical dilation

Secondary outcomes

Pain Scores Throughout Procedure at Various Time Points
Distance (mm) from the left of the 100 mm Visual Analog Scale (VAS anchors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure: * prior to medication (baseline) * after speculum insertion * with placement of PCB * with cervical dilation * with aspiration * 30 minutes post-operatively
Time frame: up to several hours

Results

Posted Jul 25, 2017

Participant flow

Participant flow — Overall Study
Milestone	4-site Injection	2-site Injection	4-Site PCB Followed by 3-minute Wait	4-site PCB Followed by no Wait
Started	83	83	83	83
Completed	83	80	80	83
Not completed	0	3	3	0
Withdrew: Protocol violation	0	3	2	0
Withdrew: Missing data	0	0	1	0

Outcome measures

PrimaryPatient Perception of Pain

To determine whether varying paracervical block techniques affect patient perception of pain. 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.

Time frame:: after completion of cervical dilation
Reported as:: Mean · mm

Patient Perception of Pain
mm	4-site Injection	2-site Injection	4-Site PCB Followed by 3-minute Wait	4-site PCB Followed by no Wait
Patient Perception of Pain	60 ± 30	68 ± 21	56 ± 32	63 ± 24

SecondaryPain Scores Throughout Procedure at Various Time Points

Distance (mm) from the left of the 100 mm Visual Analog Scale (VAS anchors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure: * prior to medication (baseline) * after speculum insertion * with placement of PCB * with cervical dilation * with aspiration * 30 minutes post-operatively

Time frame:: up to several hours
Reported as:: Mean · mm

Pain Scores Throughout Procedure at Various Time Points
mm	4-site Injection	2-site Injection	4-Site PCB Followed by 3-minute Wait	4-site PCB Followed by no Wait
Prior to medication (baseline)	7.65 ± 1.27	4.84 ± 1.30	4.2 ± 2.5	6 ± 0.9
After speculum insertion	29.35 ± 2.43	27.31 ± 2.47	29.3 ± 2.7	30.3 ± 2.7
With placement of PCB	58.89 ± 2.64	55.31 ± 2.69	60.0 ± 2.8	58.3 ± 2.8
With cervical dilation	59.76 ± 2.84	68.41 ± 2.90	55.6 ± 3.1	63.2 ± 3.1
With aspiration	67.75 ± 2.52	74.05 ± 2.56	72.1 ± 2.6	69.4 ± 2.5
30 minutes post-operatively	26.27 ± 2.56	22.37 ± 2.30	27.3 ± 2.6	24.2 ± 2.5

Adverse events

Collected over During procedure to 30 minutes post-procedure.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
4-site Injection	0/83 (0%)	0/83 (0%)	0/83 (0%)
2-site Injection	0/80 (0%)	0/80 (0%)	0/80 (0%)
4-Site PCB Followed by 3-minute Wait	0/80 (0%)	0/80 (0%)	0/80 (0%)
4-site PCB Followed by no Wait	0/83 (0%)	0/83 (0%)	0/83 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	4-site Injection	2-site Injection	4-Site PCB Followed by 3-minute Wait	4-site PCB Followed by no Wait	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	83	80	80	83	326
>=65 years	0	0	0	0	0

Age, Continuous
Age, Continuous(years)	4-site Injection	2-site Injection	4-Site PCB Followed by 3-minute Wait	4-site PCB Followed by no Wait	Total
Mean	25.2 ± 5.2	25.5 ± 5.3	25.2 ± 5.2	26.4 ± 5.5	25.575 ± 5.3

Sex: Female, Male
Sex: Female, Male(Participants)	4-site Injection	2-site Injection	4-Site PCB Followed by 3-minute Wait	4-site PCB Followed by no Wait	Total
Female	83	80	80	83	326
Male	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	4-site Injection	2-site Injection	4-Site PCB Followed by 3-minute Wait	4-site PCB Followed by no Wait	Total
United States	83	80	80	83	326

Study locations

2 sites

Oregon Health & Science University
Portland, Oregon 97239, United States
Planned Parenthood Columbia Willamette
Portland, Oregon 97239, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01466491
Lead sponsor: Oregon Health and Science University
Collaborators: Planned Parenthood Federation of America
Responsible party: Paula Bednarek (Assistant Professor, Department of Obstetrics and Gynecology, Oregon Health and Science University) — Principal investigator
First posted: Nov 8, 2011
Start date: Oct 2011
Primary completion: May 2013
Completion: May 2013
Results posted: Jul 25, 2017
Last update: Nov 8, 2019

Study contacts

Paula Bednarek, MD MPH

principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Oregon Health and Science University

Start the discussion