PainNCT02454296

Paracervical Block for Pain Associated With Laminaria Insertion

A study testing Paracervical Block with lidocaine in people with Pain, run by University of Hawaii 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

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

Who is it for?: Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: Paracervical Block with lidocaine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 1 siteUnited States
Study dates: May 2015to Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 49 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University Women's Health Specialists
Honolulu, Hawaii, 96826

Other trials in United States

About this study

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

Read the detailed 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.

Conditions: Pain
Being tested: Paracervical Block with lidocaine, Sham paracervical block
Keywords: Laminaria
Medical subject headings: Pain

What participants receive

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

Paracervical Block with lidocaineDrug
Also called Paracervical block
Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
Sham paracervical blockDrug
Also called Sham block; placebo
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

Study groups in NCT02454296
Study group	Role	What they receive
Paracervical Block with lidocaine	Active comparator	A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate. Receives: 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 Receives: Drug: Sham paracervical block

What is being measured

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

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: Measured within 10 seconds after placement of laminaria

Secondary outcomes (2)

Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)
Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied
Measured: 15 minutes post-operatively
Paracervical or Sham Block Pain
Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.
Measured: Within 10 seconds after receiving paracervical or sham block

Timeline

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

May 2015Dec 2015

First posted27 May 2015 (estimated)
Study startMay 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02454296
Sponsor's protocol ID: 22702
Status last verified: Mar 2017
First submitted: 18 May 2015
Last updated: 14 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Grimes DA, Schulz KF, Cates WJ Jr. Prevention of uterine perforation during curettage abortion. JAMA. 1984 Apr 27;251(16):2108-11.
PubMed 6708260
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.
PubMed 22525915
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
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.
PubMed 25139724
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.
PubMed 22682721
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.
PubMed 24560477
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.
PubMed 16055570
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.
PubMed 17963864
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
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
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.
PubMed 28697113

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Paracervical Block for Pain Associated With Laminaria Insertion
ClinicalTrials.gov ID: NCT02454296
Acronym / sponsor ID: 22702
Conditions: Pain
Keywords: Laminaria
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: University of HawaiiUniversity, hospital or other
Study start: May 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 27 May 2015 (estimated)
Results: Posted 14 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Paracervical Block with lidocaine	Active comparator	Drug: Paracervical Block with lidocaineA paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.
Sham paracervical block	Sham comparator	Drug: Sham paracervical blockA sham block will be done prior to the placement of laminaria using a capped needle

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Paracervical Block with lidocaineAlso: Paracervical blockPerformance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion	Drug	Paracervical Block with lidocaine
Sham paracervical blockAlso: Sham block; placeboA capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes	Drug	Sham paracervical block

Primary outcome

Pain After Placement of Laminaria (100 mm Visual Analog Scale)
Time frame: Measured within 10 seconds after placement of laminaria
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.

2 secondary outcomes

Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)
Time frame: 15 minutes post-operatively
Paracervical or Sham Block Pain
Time frame: Within 10 seconds after receiving paracervical or sham block

Results and safety

Results posted to the registry on 14 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paracervical Block With Lidocaine	20	20
Sham Paracervical Block	21	21

Primary outcome: Pain After Placement of Laminaria (100 mm Visual Analog Scale)

Time frame: Measured within 10 seconds after placement of laminaria. Median (Inter-Quartile Range). Unit: units on a scale (100 mm VAS)

Measure	Paracervical Block With Lidocaine n = 20	Sham Paracervical Block n = 21
Value	13 (2 to 39)	54 (27 to 61)

Paracervical Block With Lidocaine vs Sham Paracervical Block: p = 0.01, Wilcoxon (Mann-Whitney)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paracervical Block With Lidocaine	0 of 20 (0%)	0 of 20 (0%)	Not reported
Sham Paracervical Block	0 of 21 (0%)	0 of 21 (0%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 6708260Grimes DA, Schulz KF, Cates WJ Jr. Prevention of uterine perforation during curettage abortion. JAMA. 1984 Apr 27;251(16):2108-11.
Background: PubMed 22525915Renner 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.
Background: PubMed 15288222Kan 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.
Background: PubMed 25139724Mercier 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.
Background: PubMed 22682721Borgatta 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.
Background: PubMed 24560477Drey 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.
Background: PubMed 16055570Goldberg 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.
Background: PubMed 17963864Prairie 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.
Background: PubMed 2359559Hakim-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.
Background: PubMed 7121936Blanco LJ, Reid PR, King TM. Plasma lidocaine levels following paracervical infiltration for aspiration abortion. Obstet Gynecol. 1982 Oct;60(4):506-8.
Derived from this study: PubMed 28697113Soon 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.
Summary of lidocaine drug informationLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Principal Investigator principal investigator

University of Hawaii

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Paracervical Block with lidocaine in people with Pain, run by University of Hawaii 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 4 inclusion and 2 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 14 Apr 2017. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 After Placement of Laminaria (100 mm Visual Analog Scale) (time frame: Measured within 10 seconds after placement of laminaria). 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 NCT02454296, which also lists 11 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 14 Apr 2017.