Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
98 participants
INTERVENTIONAL
2017-05-15
2018-10-25
Brief Summary
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Detailed Description
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This prospective randomized control trial will consist of two study arms. Participants will be randomly assigned to Arm 1, where a paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol, or to Arm 2, where a paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate. Prior to the start of the study, study assignments will be generated in a 1:1 ratio.
All patients who consent to the study will receive standard counseling prior to their procedure. The procedure will start with a bimanual exam by the provider. Next, the provider will place a speculum, cleanse the cervix with betadine solution, and place a single-tooth tenaculum on the anterior lip of the cervix. At this point, participants assigned to Arm 1 will receive a paracervical block loaded with 20 cc of 1% lidocaine and injected at 2, 4, 8 and 10 o'clock positions of the cervicovaginal junction. Participants assigned to Arm 2 will receive a paracervical block loaded with 18 cc of 1% lidocaine and 2 cc of 8.4% sodium bicarbonate and inject the block in the same fashion. The research assistant will ask the patient to verbally report their level of pain based on the 100 mm visual analog scale (VAS) at the following points of the procedure:
1. Prior to the start of the procedure (baseline anxiety)
2. After speculum placement
3. After paracervical block
4. After cervical dilation
5. After suction curettage
6. At end of procedure
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
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.
Study Groups
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Standard paracervical block
A paracervical block will be administered with 20 cc of 1% lidocaine, which is our standard office protocol
Lidocaine
Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
Buffered lidocaine paracervical block
A paracervical block will be administered with 20 cc of 1% lidocaine buffered with 8.4% sodium bicarbonate
Lidocaine-Sodium Bicarbonate
Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
Interventions
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Lidocaine
Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
Lidocaine-Sodium Bicarbonate
Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Unable to provide informed consent
* Currently incarcerated
* Under the age of 14 years
* Contraindications to receiving lidocaine or buffered lidocaine
14 Years
FEMALE
Yes
Sponsors
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University of Hawaii
OTHER
Responsible Party
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Principal Investigators
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Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
University of Hawaii
Locations
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Womens Options Center
Honolulu, Hawaii, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-00083
Identifier Type: -
Identifier Source: org_study_id
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