Buffered Lidocaine in Paracervical Blocks

NCT03107754 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2017-00083
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

For pain relief during a first trimester surgical aspiration, most providers use the paracervical block, either alone or in combination with other pain control techniques. Some providers use buffered lidocaine due to a belief that it decreases pain. Others use plain lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain lidocaine in a two site injection. Few studies have compared buffered versus unbuffered lidocaine for paracervical blocks during first trimester uterine aspirations. This study seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for paracervical blocks.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Injection Pain

  For the primary outcome, pain immediately after paracervical block injection was measured by a scale. The scale used was the 100-mm visual analog scale. The minimum score was 0 and the maximum score was 100. Higher numbers indicate worse pain.

  Immediately after injection of the paracervical block

Secondary Outcomes (1)

• Pain After Speculum Placement, Cervical Dilation, and Aspiration

  Immediately after speculum placement, cervical dilation, uterine aspiration

Study Arms (2)

Standard paracervical block

PLACEBO COMPARATOR

A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol

Drug: Lidocaine

Buffered lidocaine paracervical block

EXPERIMENTAL

A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate

Drug: Lidocaine-Sodium Bicarbonate

Interventions

Lidocaine DRUG

Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain

Also known as: Paracervical anesthesia

Standard paracervical block

Lidocaine-Sodium Bicarbonate DRUG

Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain

Also known as: Buffered paracervical anesthesia

Buffered lidocaine paracervical block

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women 14 years and older
• Desiring uterine aspiration for pregnancy or surgical management of a miscarriage
• Gestational age up to 13 weeks and 6 days to be established by best dating (i.e. last menstrual period or earliest ultrasound)
• Treatment plan involves outpatient uterine aspiration
• Participant able to provide informed consent in English and willing to participate in the study

You may not qualify if:

• Unable to read, speak, or understand English
• Unable to provide informed consent
• Currently incarcerated
• Under the age of 14 years
• Contraindications to receiving lidocaine or buffered lidocaine

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (1)

Womens Options Center

Honolulu, Hawaii, 96814, United States

Location

Related Publications (11)

• Wiebe ER, Rawling M. Pain control in abortion. Int J Gynaecol Obstet. 1995 Jul;50(1):41-6. doi: 10.1016/0020-7292(95)02416-a.

  PMID: 7556858 BACKGROUND

• Renner RM, Jensen JT, Nichols MD, Edelman AB. Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials. Contraception. 2010 May;81(5):372-88. doi: 10.1016/j.contraception.2009.12.008. Epub 2010 Jan 27.

  PMID: 20399943 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

• Renner RM, Edelman AB, Nichols MD, Jensen JT, Lim JY, Bednarek PH. Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial. Contraception. 2016 Nov;94(5):461-466. doi: 10.1016/j.contraception.2016.05.005. Epub 2016 May 25.

  PMID: 27235677 BACKGROUND

• 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. doi: 10.1016/s0196-0644(96)70238-x.

  PMID: 8604867 BACKGROUND

• 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. doi: 10.1016/s0002-9378(11)91645-7.

  PMID: 1442914 BACKGROUND

• Welch MN, Czyz CN, Kalwerisky K, Holck DE, Mihora LD. Double-blind, bilateral pain comparison with simultaneous injection of 2% lidocaine versus buffered 2% lidocaine for periocular anesthesia. Ophthalmology. 2012 Oct;119(10):2048-52. doi: 10.1016/j.ophtha.2012.05.029. Epub 2012 Jul 6.

  PMID: 22771049 BACKGROUND

• Kizer NT, Zhao Q, Peipert JF, Ioffe Y, Massad LS. A randomized trial of buffered versus nonbuffered lidocaine with epinephrine for cervical loop excision. J Low Genit Tract Dis. 2014 Jan;18(1):8-12. doi: 10.1097/LGT.0b013e31828deffd.

  PMID: 23774079 BACKGROUND

• Narvaez J, Wessels I, Bacon G, Chin VR, Baqai WK, Zimmerman GJ. Prospective randomized evaluation of short-term complications when using buffered or unbuffered lidocaine 1% with epinephrine for blepharoplasty surgery. Ophthalmic Plast Reconstr Surg. 2010 Jan-Feb;26(1):33-5. doi: 10.1097/IOP.0b013e3181b80c13.

  PMID: 20090482 BACKGROUND

• Hobeich P, Simon S, Schneiderman E, He J. A prospective, randomized, double-blind comparison of the injection pain and anesthetic onset of 2% lidocaine with 1:100,000 epinephrine buffered with 5% and 10% sodium bicarbonate in maxillary infiltrations. J Endod. 2013 May;39(5):597-9. doi: 10.1016/j.joen.2013.01.008. Epub 2013 Mar 20.

  PMID: 23611375 BACKGROUND

• Harreld TK, Fowler S, Drum M, Reader A, Nusstein J, Beck M. Efficacy of a Buffered 4% Lidocaine Formulation for Incision and Drainage: A Prospective, Randomized, Double-blind Study. J Endod. 2015 Oct;41(10):1583-8. doi: 10.1016/j.joen.2015.06.017. Epub 2015 Aug 4.

  PMID: 26253800 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Anesthesia, Obstetrical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Reni Soon
• Organization: University of Hawaii

rsoon@hawaii.edu

808-983-6000

Study Officials

• Principal Investigator

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A statistician not involved with the conduct of the study will use a computer random number generator to generate random permuted blocks. This statistician will place allocation assignment cards in sequentially numbered, sealed, opaque envelopes. A different randomization scheme will be used for each location, one at the Kapi'olani office and one at the Queen's office. A clinic staff member not involved with the conduct of the study will be trained specifically in the opening of the allocation envelopes. The staff member will be trained to open the envelope and remove the study card to read the allocation group: buffered lidocaine or plain lidocaine. The clinic staff member will then prepare the buffered lidocaine or plain lidocaine in an unlabeled syringe, and place it on the surgical tray.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: May 15, 2017
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: January 5, 2021
• Results First Posted: May 15, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)