PainPhase 4NCT01466491
Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
A Phase 4 study testing Paracervical block technique with lidocaine in people with Pain, run by Oregon Health and Science University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Paracervical block technique with lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 332 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Health & Science University
Portland, Oregon, 97239
Planned Parenthood Columbia Willamette
Portland, Oregon, 97239
About this study
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.
Read the 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:
- Socio-demographic and clinical data: age, race, gravidity, parity, gestational age, prior vaginal delivery, prior abortion, level of menstrual symptoms
- 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
- Being tested
- Paracervical block technique with lidocaine
- Keywords
- Pain during first-trimester surgical abortion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracervical block technique with lidocaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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 Receives: 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). Receives: Drug: Paracervical block technique with lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after completion of cervical dilation
Secondary outcomes (1)
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
Measured: up to several hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Responsible party
- Principal investigator, Paula Bednarek, Oregon Health and Science University
- Investigators
- Paula Bednarek, MD MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466491
- Sponsor's protocol ID
- OHSU SFP 7688
- Status last verified
- Oct 2019
- First submitted
- 1 Nov 2011
- Last updated
- 8 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
- ClinicalTrials.gov ID
- NCT01466491
- Acronym / sponsor ID
- OHSU SFP 7688
- Conditions
- Pain
- Keywords
- Pain during first-trimester surgical abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Planned Parenthood Federation of America
- Study start
- Oct 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Posted 25 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Socio-demographic and clinical data: age, race, gravidity, parity, gestational age, prior vaginal delivery, prior abortion, level of menstrual symptoms
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4-site injection | Placebo comparator | Drug: Paracervical block technique with lidocaineThe 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). |
| 2-site Injection | Active comparator | Drug: Paracervical block technique with lidocaineThe 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 | Placebo comparator | Drug: Paracervical block technique with lidocaineWomen will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation |
| 4-site PCB followed by no wait | Active comparator | Drug: Paracervical block technique with lidocaineWomen will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracervical block technique with lidocaineThe 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. | Drug | 2-site Injection, 4-Site PCB followed by 3-minute wait, 4-site PCB followed by no wait, 4-site injection |
Primary outcome
Patient Perception of Pain
Time frame: 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.
1 secondary outcome
Pain Scores Throughout Procedure at Various Time Points
Time frame: up to several hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Bednarek, MD MPH principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracervical block technique with lidocaine in people with Pain, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Perception of Pain (time frame: after completion of cervical dilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.