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Rheumatic Heart DiseasePhase 1NCT00482573

Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease

A Phase 1 study testing Dental local anesthesia in people with Rheumatic Heart Disease and Pregnancy, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The hemodynamic parameters of 31 pregnant women with rheumatic valve disease, undergoing restorative dentistry under local anesthesia with 2% solution of lidocaine, divided in two groups, with (Group LE) and without 1:100,000 epinephrine solution (Group LNE), were studied by 24-hour ambulatory electrocardiographic… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Rheumatic Heart Disease, Pregnancy, Dental Caries
What is being tested?
Dental local anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteBrazil
Study dates
Apr 2004to Jan 2006
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical criteria: women with rheumatic valvar disease as diagnosed by the clinical history and physical examination, and documented by Doppler echocardiography, either having undergone surgical or percutaneous intervention before becoming pregnant or not, in functional class (FC) I or II, according to classification of the New York Heart Association (NYHA).
  • Obstetrical criteria: one fetus pregnancy, gestational age (GA) between 28 and 37 weeks.
  • Odontological criteria: total or partial dentition, with the presence of lower premolar and/or molar teeth in need of restorative dentistry due to development of dental caries (Black Class I, II and/or V), or due to the presence of restorations with edge infiltration clinically and/or radiographically diagnosed recurrent caries.

Who cannot join

  • Clinical criteria: heart failure, uncontrolled chronic arterial hypertension, or complex and/or symptomatic ventricular arrhythmia.
  • Obstetrical criteria: preeclampsia, uterine growth restriction, and labor.
  • Odontological criteria: dental caries in lower premolar or molar tooth with clinical and/or radiographic diagnosis of pulpal exposure, pulpitis, or pulpal necrosis, fracture or destruction of the tooth crown with prognostic of endodontic treatment or rehabilitation by prosthesis, or indication for extraction.
  • Psychiatric criteria: patients with anxiety disorders such as panic, agoraphobia, social or specific phobias and obsessive-compulsive disorders, posttraumatic stress, or chemically-induced anxiety, according to the classification of the American Psychiatric Association (APA).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Heart Institute (InCor) of University of São Paulo Medical School

    São Paulo, São Paulo, SP 05403-000

Other trials in Brazil

About this study

Official title: Maternal-Fetal Monitoring of Patients With Rheumatic Heart Disease During Dental Procedure Under Local Anesthesia

The hemodynamic parameters of 31 pregnant women with rheumatic valve disease, undergoing restorative dentistry under local anesthesia with 2% solution of lidocaine, divided in two groups, with (Group LE) and without 1:100,000 epinephrine solution (Group LNE), were studied by 24-hour ambulatory electrocardiographic monitoring, intermittent blood pressure monitoring and continuous cardiotocography, during three standard time periods. A significant decrease in the values of maternal heart rate was seen during the procedure, in comparison with the other two time periods in the two groups, as well as, the occurrence of cardiac arrhythmia in 9 (29.1%) patients, being 7 (41.8%) of them in the group receiving epinephrine anesthesia. We conclude the use of 2% lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valve disease.

Read the detailed description

During pregnancy, the organic systems of a woman are subjected to physiological modifications consequential to hormonal, anatomic and metabolical alterations. The most significant modification in the circulatory system is an increased cardiac output from the first three months of gestation. Women with heart disease may present with severe complications during the gestational period, because of inappropriate adaptation of her body to this hemodynamic overload, even those patients who are thought to have an appropriate functional capacity during early pregnancy. There are scant studies in the literature on the effects of local anesthetics, with and without vasoconstrictor, used in dental procedures on the cardiovascular variables of pregnant women with valvar disease, as well as on their concepti. Driven by this shortage, we decided to have this subject studied, by assessing and analyzing cardiotocographic parameters, such as fetal heart rate (FHR), fetal motility(FM) and uterine contractions (UC), in addition to blood pressure (BP) and electrocardiographic variables, such as heart rate (HR) and extrasystoles (ES), in pregnant women with rheumatic valvar disease who undergo local anesthesia with lidocaine, with and without vasoconstrictor, during restorative dental procedure. For this, 31 rheumatic heart disease patients who were in their 28th to 37th week of gestation, had 24-hour ambulatory monitoring of their BP and Holter electrocardiography (Holter-ECG), and cardiotocography (CTG), performed during: (1) baseline - 60 minutes before the procedure for BP and Holter-ECG monitoring, and 20 minutes before the procedure for CTG; (2) procedure - 56±15.5 minutes (mean±SD); (3) post-procedure - 20 minutes; and (4) mean 24-hour HR and ES measurement, and mean wake and sleeping periods BP monitoring. Variation of the above variables was analyzed in two groups, one with infusion of a 2% solution of lidocaine without vasoconstrictor (Group LNE) composed of 14 patients, and the other with infusion of a 2% solution of lidocaine with epinephrine 1:100,000 (Group LE) composed of 17 patients, randomized drawing and single blind. The investigator wise person which solution of lidocaine was being used, therefore the proper local vasoconstriction denounced if it was infiltrated or not epinephrine. The used technique was of the modified periodontal ligament (PDLm injection), by means of the equipment The Wand, infusing 1.8 ml (one cartridge) in six minutes. We use the technique of analysis of variance (ANOVA) with repeated measures to calculate the size of the sample and for the analysis and multiple interpretation of the variable in three distinct periods, on the basis of the table of Vonesh and Shork (15 patients in each group, considering a correlation enters the measures of next value the 0,4, a level of significance of 5% and to be able of test of 80%). All the variable had been initially analyzed descriptive. For the quantitative variable this analysis was made through the comment of the minimum and maximum values, and of the calculation of medium averages and shunting line-standard and. For the qualitative variable we calculate absolute and relative frequencies. The level of significance used for the tests was of 5% (p<0,05).The maternal HR values obtained during the procedure showed a significant reduction only in comparison with the other time periods (P<0.001)in the two groups. The comparison of the groups LE e LNE did not reveal any significant difference (P>0.05). ES was detected in 9 (29.0%) patients, being 7 of them (41.8%) from the Group LE. BP did not show any significant difference neither between time periods, nor between groups (P>0.05). The same occurred in the comparative analysis of the fetal parameters obtained during CTG - number of UC, level and variability from baseline of the FHR, number of accelerations of the FHR and fetal reactivity pattern. Our conclusion was that the use of 2% solution of lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valvar cardiopathy.

Being tested
Dental local anesthesia
Keywords
Electrocardiography, ambulatory/methods, Blood Pressure monitoring, ambulatory/methods, Cardiotocography/methods, Dental restoration, permanent, Anesthesia, local /methods, Lidocaine, Vasoconstrictor Agents, Epinephrine, Pregnancy, Rheumatic Heart Disease
Medical subject headings
Rheumatic Heart Disease, Dental Caries

What participants receive

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

  • Dental local anesthesiaProcedure or surgery

    Also called Alphacaine® 2% with epinephrine 1:100,000 - DFL, - fab/man 06/2003 - val/exp 06/2005 - lot 0306D11 and, - fab/man 04/2004 - val/exp 04/2006 - lot 0404D05

    • 2% lidocaine solution with epinephrine 1:100,000
    • infusion of 1,8 mL (one cartridge)
    • Technic: modified anesthesia of the periodontal ligament (PDLm injection) was performed applying The Wand II Computerized System (Milestone International)

  • Dental local anesthesiaProcedure or surgery

    Also called Xylestesin® 2% without vasoconstrictor - Cristália, - fab/man 06/2003 - val/exp 06/2006 - lot 3062010

    • 2% lidocaine solution without vasoconstrictor
    • infusion of 1,8 mL (one cartridge)
    • Technic: modified anesthesia of the periodontal ligament (PDLm injection) was performed applying The Wand II Computerized System (Milestone International)
Study groups in NCT00482573
Study groupRoleWhat they receive
Group LEExperimentalSeventeen (54.8%) patients, composed group LE, were randomly assigned for the infusion of 1.8 mL (one cartridge) by the modified anesthesia into the periodontal ligament (PDLm injection) of 2% lidocaine solution with epinephrine 1:100,000. Their ages were ranging from 18 to 44 years (mean:29.6), they were diagnosed as having rheumatic valve disease, in a functional class I or II according to classification of the NYHA. Gestation age ranged from 28 to 36 weeks (mean:31.8), and the BMI from 18.7 to 32.9 (mean:23.8) kg/m2. All the patients had the restauration done in their inferior premolar and/or molar teeth.
Receives: Procedure: Dental local anesthesia
Group LNEActive comparatorFourteen (45.2%) patients, composed group LNE, were randomly assigned for the infusion of 1.8 mL (one cartridge) by the modified anesthesia into the periodontal ligament (PDLm injection) of 2% lidocaine solution without epinephrine. Their ages were ranging from 22 to 33 years (mean:26.6), they were diagnosed as having rheumatic valve disease, in a functional class I or II according to classification of the NYHA. Gestation age ranged from 29 to 37 weeks (mean:32.1), and the BMI from 18.5 to 38.1 (mean:22.8) kg/m2. All the patients had the restauration done in their inferior premolar and/or molar teeth.
Receives: Procedure: Dental local anesthesia

What is being measured

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

  1. Maternal: Blood Pressure, Heart Rate and Extrasystoles; Maternal-Fetal: Fetal Heart Rate, number of uterine contractions, motility and fetal reactivity pattern, in function of presence or not of epinephrine 1:100000 in the 2% solution.of lidocaine

    Measured: 4 periods Maternal: (1) Baseline - 60 minutes before the procedure, (2) Procedure, (3) Post-Procedure - 20 minutes, and (4) mean 24-hour; 3 periods Maternal-Fetal: (1) Baseline: 20 minutes before, (2) Procedure, and (3) Post-Procedure - idem maternal

Secondary outcomes (1)

  1. They had been the same analyses used for the Primary Outcome Measures, in function of the gestational age (GA): sub-group GA1 (15 pregnant women between 28 and 31 weeks) and sub-group GA2 (16 pregnant women between 28 and 31 weeks).

    Measured: They had been the same periods established for the Time Frame of Primary Outcome Measure

Timeline

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

  1. First posted5 Jun 2007 (estimated)
  2. Study startApr 2004
  3. Primary completionJul 2005
  4. Study completionJan 2006

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00482573
Sponsor's protocol ID
CAPPesq 009/03
Status last verified
Jun 2008
First submitted
4 Jun 2007
Last updated
5 Jun 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Dajani AS, Taubert KA, Wilson W, Bolger AF, Bayer A, Ferrieri P, Gewitz MH, Shulman ST, Nouri S, Newburger JW, Hutto C, Pallasch TJ, Gage TW, Levison ME, Peter G, Zuccaro G Jr. Prevention of bacterial endocarditis. Recommendations by the American Heart Association. Circulation. 1997 Jul 1;96(1):358-66. doi: 10.1161/01.cir.96.1.358.

    PubMed 9236458

  • Aellig WH, O'Neil R, Laurence DR, Verrill PJ. Cardiac effects of adrenaline and felypressin as vasoconstrictors in local anaesthesia for oral surgery under diazepam sedation. Br J Anaesth. 1970 Feb;42(2):174-6. doi: 10.1093/bja/42.2.174. No abstract available.

    PubMed 5440531

  • Ahn J, Pogrel MA. The effects of 2% lidocaine with 1:100,000 epinephrine on pulpal and gingival blood flow. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Feb;85(2):197-202. doi: 10.1016/s1079-2104(98)90426-7.

    PubMed 9503456

  • AKUTSU A, CHIBA T, TAKAHASHI H, SHIMODA M, SUEMATSU T. MANAGEMENT OF DENTAL PROBLEMS IN PATIENTS WITH CARDIOVASCULAR DISEASE. J Am Dent Assoc. 1964 Mar;68:333-42. doi: 10.14219/jada.archive.1964.0104. No abstract available.

    PubMed 14128020

  • Anwari JS, Butt AA, Al-Dar MA. Obstetric admissions to the intensive care unit. Saudi Med J. 2004 Oct;25(10):1394-9.

    PubMed 15494809

  • Asghar F, Kokab H. Evaluation and outcome of pregnancy complicated by heart disease. J Pak Med Assoc. 2005 Oct;55(10):416-9.

    PubMed 16304847

  • Assem ES, Punnia-Moorthy A. Allergy to local anaesthetics: an approach to definitive diagnosis. A review with an illustrative study. Br Dent J. 1988 Jan 23;164(2):44-7. doi: 10.1038/sj.bdj.4806337. No abstract available.

    PubMed 2449232

  • AXELROD J. Metabolism of epinephrine and other sympathomimetic amines. Physiol Rev. 1959 Oct;39:751-76. doi: 10.1152/physrev.1959.39.4.751. No abstract available.

    PubMed 13795318

  • Beller GA, Smith TW, Abelmann WH, Haber E, Hood WB Jr. Digitalis intoxication. A prospective clinical study with serum level correlations. N Engl J Med. 1971 May 6;284(18):989-97. doi: 10.1056/NEJM197105062841801. No abstract available.

    PubMed 5553483

  • Bennett JA, Riegel B, Bittner V, Nichols J. Validity and reliability of the NYHA classes for measuring research outcomes in patients with cardiac disease. Heart Lung. 2002 Jul-Aug;31(4):262-70. doi: 10.1067/mhl.2002.124554.

    PubMed 12122390

  • Brent RL. Commentary on JAMA article by Hujoel et al. Health Phys. 2005 Apr;88(4):379-81. doi: 10.1097/01.hp.0000152109.40007.35.

    PubMed 15761300

  • Bryant EE, Douglas BH, Ashburn AD. Circulatory changes following prolactin administration. Am J Obstet Gynecol. 1973 Jan 1;115(1):53-7. doi: 10.1016/0002-9378(73)90088-4. No abstract available.

    PubMed 4344064

  • Bush RK, Taylor SL, Holden K, Nordlee JA, Busse WW. Prevalence of sensitivity to sulfiting agents in asthmatic patients. Am J Med. 1986 Nov;81(5):816-20. doi: 10.1016/0002-9343(86)90351-7.

    PubMed 3535492

  • Capeless EL, Clapp JF. Cardiovascular changes in early phase of pregnancy. Am J Obstet Gynecol. 1989 Dec;161(6 Pt 1):1449-53. doi: 10.1016/0002-9378(89)90902-2.

    PubMed 2603897

  • Caruana P, Pateromichelakis S, Rood JP. The effects of adrenaline on lignocaine nerve block anaesthesia. J Dent. 1982 Jun;10(2):140-3. doi: 10.1016/s0300-5712(82)80008-0. No abstract available.

    PubMed 6955323

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dental local anesthesia in people with Rheumatic Heart Disease and Pregnancy, run by University of Sao Paulo at 1 site in Brazil.

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 3 inclusion and 4 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 5 Jun 2008. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maternal: Blood Pressure, Heart Rate and Extrasystoles; Maternal-Fetal: Fetal Heart Rate, number of uterine contractions, motility and fetal reactivity pattern, in function of presence or not of epinephrine 1:100000 in the 2% solution.of lidocaine (time frame: 4 periods Maternal: (1) Baseline - 60 minutes before the procedure, (2) Procedure, (3) Post-Procedure - 20 minutes, and (4) mean 24-hour; 3 periods Maternal-Fetal: (1) Baseline: 20 minutes before, (2) Procedure, and (3) Post-Procedure - idem maternal). 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 NCT00482573, which also lists 227 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 5 Jun 2008.

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