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

NCT ID: NCT01466491

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-05-31

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

Paracervical block technique with lidocaine

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Paracervical block technique with lidocaine

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

Paracervical block technique with lidocaine

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

Paracervical block technique with lidocaine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Planned Parenthood Federation of America

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Paula Bednarek

Assistant Professor, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paula Bednarek, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Planned Parenthood Columbia Willamette

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU SFP 7688

Identifier Type: -

Identifier Source: org_study_id