Paracervical Block for Pain Associated With Laminaria Insertion

Pain Clinical Trial

Official title:

Paracervical Block for Pain Associated With Laminaria Insertion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02454296
• Other study ID #: 22702
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2015
• Last updated: November 30, 2015
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: University of Hawaii
• Contact: Principal Investigator
• Phone: (808) 203-6500
• Email: research[@]fpfellowshiphawaii.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.

Description:

Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Pregnant women between the ages of 18-49 years

• Desiring surgical termination of pregnancy or surgical management of a fetal demise

• Treatment plan involves cervical preparation with laminaria

• Participant able to provide informed consent in English and willing to participate in the study

Exclusion Criteria:

• Unable to read/speak/understand English

• Contraindications to receiving lidocaine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Paracervical Block with lidocaine
Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
• Sham paracervical block
A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes

Locations

Country	Name	City	State
United States	University Women's Health Specialists	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
University of Hawaii

Country where clinical trial is conducted

United States, 

References & Publications (10)

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

Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6. — View Citation

Drey EA, Benson LS, Sokoloff A, Steinauer JE, Roy G, Jackson RA. Buccal misoprostol plus laminaria for cervical preparation before dilation and evacuation at 21-23 weeks of gestation: a randomized controlled trial. Contraception. 2014 Apr;89(4):307-13. doi: 10.1016/j.contraception.2013.10.013. Epub 2013 Nov 4. — View Citation

Goldberg AB, Drey EA, Whitaker AK, Kang MS, Meckstroth KR, Darney PD. Misoprostol compared with laminaria before early second-trimester surgical abortion: a randomized trial. Obstet Gynecol. 2005 Aug;106(2):234-41. — View Citation

Grimes DA, Schulz KF, Cates WJ Jr. Prevention of uterine perforation during curettage abortion. JAMA. 1984 Apr 27;251(16):2108-11. — 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

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

Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23. — View Citation

Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. Contraception. 2007 Nov;76(5):383-8. Epub 2007 Oct 4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain after placement of laminaria (100 mm VAS)	The research assistant will assess the participant's pain on the 100 mm VAS	Measured within 10 seconds after placement of laminaria	No
Secondary	Satisfaction with overall pain control and the overall procedure (100 mm VAS)	Patients will rate satisfaction on the 100 mm VAS	15 minutes post-operatively	No
Secondary	Pain during other steps in the laminaria insertion procedure (100 mm VAS)	Patients will rate pain on the 100 mm VAS	Pain will be measured at baseline; within 10 seconds after placement of speculum; within 10 seconds of paracervical block or sham block; 15 minutes after end of procedure	No