Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
- Registration Number
- NCT01466491
- Lead Sponsor
- Oregon Health and Science University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 332
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4-site injection Paracervical block technique with lidocaine 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). 4-site PCB followed by no wait Paracervical block technique with lidocaine Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0). 2-site Injection Paracervical block technique with lidocaine 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). 4-Site PCB followed by 3-minute wait Paracervical block technique with lidocaine Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation
- Primary Outcome Measures
Name Time Method Patient Perception of Pain after completion of cervical dilation 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.
- Secondary Outcome Measures
Name Time Method Pain Scores Throughout Procedure at Various Time Points up to several hours 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
Trial Locations
- Locations (2)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Planned Parenthood Columbia Willamette
🇺🇸Portland, Oregon, United States