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Legal Abortion With ComplicationPhase 4NCT01094366

Paracervical Block for Pain Control in First Trimester Abortion

A Phase 4 study testing Paracervical Block in people with Legal Abortion With Complication and Pain, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many woman undergoing a surgical abortion receive a paracervical nerve block for pain reduction, in which lidocaine (a numbing medication) is injected around the cervix. These injections numb the cervix and possibly the lower part of the uterus. Read more about this study

Who is it for?
Ages 18 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Legal Abortion With Complication, Pain
What is being tested?
Paracervical Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
1 siteUnited States
Study dates
Apr 2010to Nov 2012
Phase
Phase 4
Are there results?
None posted in the registry

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 60 years
  • Women only
  • Healthy volunteers accepted
  • 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
  • Good general health
  • English or Spanish speaking
  • Be able and willing to sign an informed consent and agree to terms of the study

Who cannot join

  • Gestational ages over 11 0/7 weeks, due to routine misoprostol use at our institutions
  • Incomplete abortion
  • Required or requested narcotics or IV sedation (prior to randomization)
  • Patients who refuse Ibuprofen and paracervical blocks
  • Contraindications or allergies to lidocaine, ibuprofen or ativan
  • Significant physical or mental health condition
Show all 9Show fewer
  • Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
  • Patients with known hepatic disease
  • Women, who in the opinion of the investigator are not suitable for the study protocol

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Planned Parenthood Columbia Willamette

    Portland, Oregon, 97212

Other trials in United States

About this study

Official title: An Evaluation of the Paracervical Block for Pain Control in First Trimester Surgical Abortion

Many woman undergoing a surgical abortion receive a paracervical nerve block for pain reduction, in which lidocaine (a numbing medication) is injected around the cervix. These injections numb the cervix and possibly the lower part of the uterus. However, the injection can be uncomfortable and it is not well known whether it is effective in reducing pain. The purpose of this study is to determine the level of pain women experience with a surgical abortion and the effect that paracervical block might have on that pain.

Read the detailed description

The investigators expect to have 120 women complete this study, between study sites at OHSU's Center for Women's Health and Planned Parenthood Columbia Willamette in Portland, OR. Every participant will still receive the standard oral medication for pain (ibuprofen) and anxiety (lorazepam). Eligible subjects will be at least 18 years of age, less than 11 weeks pregnant and have already decided to have a surgical abortion.

The primary outcome evaluated will be pain reported at time of cervical dilation. The investigators will assess pain at various time points (including secondary outcomes) immediately upon completion of the respective step and pain and satisfaction 30 minutes postoperatively.

Being tested
Paracervical Block, Sham Paracervical Block
Keywords
Paracervical Block, pain control, abortion
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paracervical BlockProcedure or surgery

    Subject receives 20 mL paracervical block with 18 mL of 1% Lidocaine solution buffered with 2 mL 8.4% sodium bicarbonate for pain control.

  • Sham Paracervical BlockProcedure or surgery

    In the non-intervention group, the surgeon performs a sham PCB during which 2 mL buffered lidocaine solution are injected at the tenaculum site, after which a capped needle gently simulates the standard PCB procedure.

Study groups in NCT01094366
Study groupRoleWhat they receive
No Paracervical Block for Pain ControlSham comparatorSubject will not receive a paracervical block during the procedure
Receives: Procedure: Sham Paracervical Block
Paracervical Block for Pain ControlActive comparatorSubject will receive a paracervical block during the procedure.
Receives: Procedure: Paracervical Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain reported with cervical dilation

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of cervical dilation.

    Measured: 1 Year

Secondary outcomes (4)

  1. Anticipated and reported pain at various time points

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of anticipated pain) recorded prior to the procedure.

    Distance (mm) from the left of the 100-mm VAS scale (reflecting magnitude of pain) recorded at time of positioning for procedure, speculum insertion, placement of the PCB, aspiration and 30 min postoperatively.

    Measured: 1 Year

  2. Anxiety reported with the pain expected during the procedure and the procedure itself.

    Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of anxiety) recorded prior to procedure.

    Measured: 1 Year

  3. Satisfaction reported with pain control and overall procedure

    Distance (mm) from the left of the 100-mm VAS scale (reflecting degree of satisfaction) recorded post procedure.

    Measured: 1 Year

  4. Need for additional intraoperative and/or postoperative pain medication

    Subjects may request additional pain medication once their procedure has begun or in recovery. The need for additional medication, and what medication was subsequently distributed, will be recorded.

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionOct 2010
  4. Study completionNov 2012

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01094366
Sponsor's protocol ID
OHSU IRB 6071
Status last verified
Dec 2019
First submitted
25 Mar 2010
Last updated
27 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Allen RH, Kumar D, Fitzmaurice G, Lifford KL, Goldberg AB. Pain management of first-trimester surgical abortion: effects of selection of local anesthesia with and without lorazepam or intravenous sedation. Contraception. 2006 Nov;74(5):407-13. doi: 10.1016/j.contraception.2006.06.002. Epub 2006 Aug 2.

    PubMed 17046383

  • Belanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989 Mar;36(3):339-350. doi: 10.1016/0304-3959(89)90094-8.

    PubMed 2710563

  • Berger GS, Tyler CW, Harrod EK. Maternal deaths associated with paracervical block anesthesia. Am J Obstet Gynecol. 1974 Apr 15;118(8):1142-3. doi: 10.1016/0002-9378(74)90698-x. No abstract available.

    PubMed 4817653

  • Blanco LJ, Reid PR, King TM. Plasma lidocaine levels following paracervical infiltration for aspiration abortion. Obstet Gynecol. 1982 Oct;60(4):506-8.

    PubMed 7121936

  • Cetin A, Cetin M. Effect of deep injections of local anesthetics and basal dilatation of cervix in management of pain during legal abortions. A randomized, controlled study. Contraception. 1997 Aug;56(2):85-7. doi: 10.1016/s0010-7824(97)00096-6.

    PubMed 9315416

  • Donati S, Medda E, Proietti S, Rizzo L, Spinelli A, Subrizi D, Grandolfo ME. Reducing pain of first trimester abortion under local anaesthesia. Eur J Obstet Gynecol Reprod Biol. 1996 Dec 27;70(2):145-9. doi: 10.1016/s0301-2115(95)02583-9.

    PubMed 9119094

  • Edelman A, Nichols MD, Leclair C, Astley S, Shy K, Jensen JT. Intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2004 Jun;103(6):1267-72. doi: 10.1097/01.AOG.0000127981.53911.0e.

    PubMed 15172863

  • Edelman A, Nichols MD, Leclair C, Jensen JT. Four percent intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2006 Feb;107(2 Pt 1):269-75. doi: 10.1097/01.AOG.0000194204.71925.4a.

    PubMed 16449111

  • Glantz JC, Shomento S. Comparison of paracervical block techniques during first trimester pregnancy termination. Int J Gynaecol Obstet. 2001 Feb;72(2):171-8. doi: 10.1016/s0020-7292(00)00292-7.

    PubMed 11166751

  • Gomez PI, Gaitan H, Nova C, Paradas A. Paracervical block in incomplete abortion using manual vacuum aspiration: randomized clinical trial. Obstet Gynecol. 2004 May;103(5 Pt 1):943-51. doi: 10.1097/01.AOG.0000123269.86525.c4.

    PubMed 15121569

  • Grimes DA, Cates W Jr. Deaths from paracervical anesthesia used for first-trimester abortion, 1972-1975. N Engl J Med. 1976 Dec 16;295(25):1397-9. doi: 10.1056/NEJM197612162952503.

    PubMed 980095

  • Hakim-Elahi E, Tovell HM, Burnhill MS. Complications of first-trimester abortion: a report of 170,000 cases. Obstet Gynecol. 1990 Jul;76(1):129-35.

    PubMed 2359559

  • Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.

    PubMed 14622683

  • Kan AS, Caves N, Wong SY, Ng EH, Ho PC. A double-blind, randomized controlled trial on the use of a 50:50 mixture of nitrous oxide/oxygen in pain relief during suction evacuation for the first trimester pregnancy termination. Hum Reprod. 2006 Oct;21(10):2606-11. doi: 10.1093/humrep/del234. Epub 2006 Jun 21.

    PubMed 16790607

  • Kan AS, Ng EH, Ho PC. The role and comparison of two techniques of paracervical block for pain relief during suction evacuation for first-trimester pregnancy termination. Contraception. 2004 Aug;70(2):159-63. doi: 10.1016/j.contraception.2004.03.013.

    PubMed 15288222

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paracervical Block in people with Legal Abortion With Complication and Pain, run by Oregon Health and Science University at 1 site 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 9 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 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pain reported with cervical dilation (time frame: 1 Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01094366, which also lists 34 linked publications.

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 27 Dec 2019.

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