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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Paracervical block technique with lidocaine

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

• Study Type: Interventional
• Enrollment (Actual): 332
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.
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; 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.
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; 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 is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Planned Parenthood Federation of America
• Investigators: Principal Investigator: Paula Bednarek, MD MPH, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 1, 2011
• First Submitted That Met QC Criteria: November 3, 2011
• First Posted (Estimate): November 8, 2011

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Pain during first-trimester surgical abortion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: OHSU SFP 7688