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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466491
• Other study ID #: OHSU SFP 7688
• Status: Completed
• Phase: Phase 4
• Start date: October 2011
• Est. completion date: May 2013

Study information

• Verified date: October 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Paracervical 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon
United States	Planned Parenthood Columbia Willamette	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Planned Parenthood Federation of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after completion of cervical dilation
Secondary	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	up to several hours