Paracervical Block for Pain Associated With Laminaria Insertion

NCT02454296 | Completed Results

• 1 other identifier: 22702
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Laminaria

Outcome Measures

Primary Outcomes (1)

• Pain After Placement of Laminaria (100 mm Visual Analog Scale)

  We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.

  Measured within 10 seconds after placement of laminaria

Secondary Outcomes (2)

• Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)

  15 minutes post-operatively

• Paracervical or Sham Block Pain

  Within 10 seconds after receiving paracervical or sham block

Study Arms (2)

Paracervical Block with lidocaine

ACTIVE COMPARATOR

A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.

Drug: Paracervical Block with lidocaine

Sham paracervical block

SHAM COMPARATOR

A sham block will be done prior to the placement of laminaria using a capped needle

Drug: Sham paracervical block

Interventions

Paracervical Block with lidocaine DRUG

Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion

Also known as: Paracervical block

Paracervical Block with lidocaine

Sham paracervical block DRUG

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

Also known as: Sham block; placebo

Sham paracervical block

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Unable to read/speak/understand English
• Contraindications to receiving lidocaine

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (1)

University Women's Health Specialists

Honolulu, Hawaii, 96826, United States

Location

Related Publications (11)

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

  PMID: 6708260 BACKGROUND

• 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.

  PMID: 22525915 BACKGROUND

• 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.

  PMID: 15288222 BACKGROUND

• 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.

  PMID: 25139724 BACKGROUND

• 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.

  PMID: 22682721 BACKGROUND

• 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.

  PMID: 24560477 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000168629.17326.00.

  PMID: 16055570 BACKGROUND

• 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. doi: 10.1016/j.contraception.2007.07.008. Epub 2007 Oct 4.

  PMID: 17963864 BACKGROUND

• 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.

  PMID: 2359559 BACKGROUND

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

  PMID: 7121936 BACKGROUND

• Soon R, Tschann M, Salcedo J, Stevens K, Ahn HJ, Kaneshiro B. Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):387-392. doi: 10.1097/AOG.0000000000002149.

  PMID: 28697113 DERIVED

Related Links

• Summary of lidocaine drug information

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, Obstetrical; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

1. Overall pain scores lower than in other published studies - speaks to generalizability 2. Paracervical block formulation might not be what is commonly used elsewhere 3. 76% of participants were able to correctly guess their group allocation

Results Point of Contact

• Title: Reni Soon, MD
• Organization: University of Hawaii

rsoon@hawaii.edu

808-203-6548

Study Officials

• Principal Investigator

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 27, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)