Paracervical Block for Pain Control in First Trimester Abortion
NCT ID: NCT01094366
Last Updated: 2019-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
121 participants
INTERVENTIONAL
2010-04-30
2012-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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No Paracervical Block for Pain Control
Subject will not receive a paracervical block during the procedure
Sham Paracervical Block
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.
Paracervical Block for Pain Control
Subject will receive a paracervical block during the procedure.
Paracervical Block
Subject receives 20 mL paracervical block with 18 mL of 1% Lidocaine solution buffered with 2 mL 8.4% sodium bicarbonate for pain control.
Interventions
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Paracervical Block
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 Block
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
60 Years
FEMALE
Yes
Sponsors
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Planned Parenthood Federation of America
OTHER
Oregon Health and Science University
OTHER
Responsible Party
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Principal Investigators
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Regina M Renner, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Planned Parenthood Columbia Willamette
Portland, Oregon, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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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.
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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.
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.
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Miller L, Jensen MP, Stenchever MA. A double-blind randomized comparison of lidocaine and saline for cervical anesthesia. Obstet Gynecol. 1996 Apr;87(4):600-4. doi: 10.1016/0029-7844(95)00463-7.
Nichols, M. D., Halvorson-Boyd, G., Goldstein, R., Gevirtz, C., & Healow, D. (2009). Pain management. In M. Paul, E. S. Lichtenberg, L. Borgatta, D. A. Grimes & P. G. Stubblefield (Eds.), Management of unintended and abnormal pregnancy. (pp. 90-110): Wiley-Blackwell.
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Safe Abortion: Technical and Policy Guidance for Health Systems. 2nd edition. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK138196/
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Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e.
Other Identifiers
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OHSU IRB 6071
Identifier Type: -
Identifier Source: org_study_id