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

NCT01466491 | Completed Phase 4 Results

• 1 other identifier: OHSU SFP 7688
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain

Keywords

Pain during first-trimester surgical abortion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain Scores Throughout Procedure at Various Time Points

  up to several hours

Study Arms (4)

4-site injection

PLACEBO COMPARATOR

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

2-site Injection

ACTIVE COMPARATOR

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

4-Site PCB followed by 3-minute wait

PLACEBO COMPARATOR

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

4-site PCB followed by no wait

ACTIVE COMPARATOR

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

Paracervical block technique with lidocaine DRUG

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.

2-site Injection; 4-Site PCB followed by 3-minute wait; 4-site PCB followed by no wait; 4-site injection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Planned Parenthood Federation of America: collaborator

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Planned Parenthood Columbia Willamette

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Paula Bednarek
• Organization: Oregon Health & Science University

whru@ohsu.edu

503-494-3666

Study Officials

• Paula Bednarek, MD MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 8, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 8, 2019
• Results First Posted: July 25, 2017

Record last verified: 2019-10

Locations

US (2)