Paracervical Block for Pain Control in First Trimester Abortion

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01094366
• Other study ID #: OHSU IRB 6071
• Status: Completed
• Phase: Phase 4
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: December 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: November 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Legal Abortion With Complication
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Planned Parenthood Columbia Willamette	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Planned Parenthood Federation of America

Country where clinical trial is conducted

United States, 

References & Publications (33)

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. Epub 2006 Aug 2. — View Citation

Bélanger E, Melzack R, Lauzon P. Pain of first-trimester abortion: a study of psychosocial and medical predictors. Pain. 1989 Mar;36(3):339-50. — View Citation

Berger GS, Tyler CW, Harrod EK. Maternal deaths associated with paracervical block anesthesia. Am J Obstet Gynecol. 1974 Apr 15;118(8):1142-3. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Glantz JC, Shomento S. Comparison of paracervical block techniques during first trimester pregnancy termination. Int J Gynaecol Obstet. 2001 Feb;72(2):171-8. — View Citation

Gómez PI, Gaitán 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Jun 21. — View Citation

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. — View Citation

López JC, Vigil-De Gracia P, Vega-Malek JC, Ruiz E, Vergara V. A randomized comparison of different methods of analgesia in abortion using manual vacuum aspiration. Int J Gynaecol Obstet. 2007 Nov;99(2):91-4. Epub 2007 Jul 12. — View Citation

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. — View Citation

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.

O'Connell K, Jones HE, Simon M, Saporta V, Paul M, Lichtenberg ES; National Abortion Federation Members. First-trimester surgical abortion practices: a survey of National Abortion Federation members. Contraception. 2009 May;79(5):385-92. doi: 10.1016/j.contraception.2008.11.005. Epub 2008 Dec 11. — View Citation

Owolabi OT, Moodley J. A randomized trial of pain relief in termination of pregnancy in South Africa. Trop Doct. 2005 Jul;35(3):136-9. — View Citation

Phair N, Jensen JT, Nichols MD. Paracervical block and elective abortion: the effect on pain of waiting between injection and procedure. Am J Obstet Gynecol. 2002 Jun;186(6):1304-7. — View Citation

Rabin JM, Spitzer M, Dwyer AT, Kaiser IH. Topical anesthesia for gynecologic procedures. Obstet Gynecol. 1989 Jun;73(6):1040-4. — View Citation

Renner RM, Jensen JT, Nichols MD, Edelman A. Pain control in first trimester surgical abortion. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD006712. doi: 10.1002/14651858.CD006712.pub2. Review. — View Citation

Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-2. Review. — View Citation

Smith GM, Stubblefield PG, Chirchirillo L, McCarthy MJ. Pain of first-trimester abortion: its quantification and relations with other variables. Am J Obstet Gynecol. 1979 Mar 1;133(5):489-98. — View Citation

Strauss LT, Gamble SB, Parker WY, Cook DA, Zane SB, Hamdan S; Centers for Disease Control and Prevention (CDC). Abortion surveillance--United States, 2004. MMWR Surveill Summ. 2007 Nov 23;56(9):1-33. — View Citation

Suprapto K, Reed S. Naproxen sodium for pain relief in first-trimester abortion. Am J Obstet Gynecol. 1984 Dec 15;150(8):1000-1. — View Citation

Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. — View Citation

WHO. (2003). Safe abortion:Technical and policy guidance for health systems

Wiebe E, Podhradsky L, Dijak V. The effect of lorazepam on pain and anxiety in abortion. Contraception. 2003 Mar;67(3):219-21. — View Citation

Wiebe ER, Rawling M. Pain control in abortion. Int J Gynaecol Obstet. 1995 Jul;50(1):41-6. — View Citation

Wiebe ER. Comparison of the efficacy of different local anesthetics and techniques of local anesthesia in therapeutic abortions. Am J Obstet Gynecol. 1992 Jul;167(1):131-4. — View Citation

Zullo F, Pellicano M, Stigliano CM, Di Carlo C, Fabrizio A, Nappi C. Topical anesthesia for office hysteroscopy. A prospective, randomized study comparing two modalities. J Reprod Med. 1999 Oct;44(10):865-9. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Year
Secondary	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.	1 Year
Secondary	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.	1 Year
Secondary	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.	1 Year
Secondary	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.	1 Year