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Cervical Intraepithelial NeoplasiaPhase 4HSBAPCBNCT02368054

Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization

A Phase 4 study testing Bupivacaine and Adrenaline in people with Cervical Intraepithelial Neoplasia, run by Helse Fonna at 1 site in Norway.

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

Cervical conization is done for pre-cancer disease. The procedure is performed with local anesthesia and general anesthesia. Local anesthesia is given by paracervical block, and several different local anesthetics is being used including bupivacaine with and without adrenaline. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Cervical Intraepithelial Neoplasia
What is being tested?
Bupivacaine and Adrenaline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteNorway
Study dates
May 2015to Feb 2016
Phase
Phase 4
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Clinical diagnosis of cervical pre-cancer

Who cannot join

  • Pregnancy
  • Feeding mother
  • Bad nutritional state
  • Infection
  • Treatment for hypertension
  • Diabetes for many years or complications
Show all 11Show fewer
  • Cardiovascular disease
  • Serious anemia
  • Cardial arrythmia
  • Serious liver-disease
  • Hypersensitivity to local anesthesia of amide-type

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Kirurgisk Klinikk-Anestesi

    Haugesund, Rogaland, 5504

Other trials in Norway

About this study

Official title: Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization During General Anesthesia: A Randomized Controlled Double Blinded Study

Cervical conization is done for pre-cancer disease. The procedure is performed with local anesthesia and general anesthesia. Local anesthesia is given by paracervical block, and several different local anesthetics is being used including bupivacaine with and without adrenaline. Adrenaline might reduce local bleeding and reduce toxicity of bupivacaine by reducing absorption, but might affect cardiovascular function. This study will examine this effect.

Read the detailed description

Most patients scheduled for cervical conization are healthy, young women. Some do this procedure with local anesthesia (paracervical block) and sedation, others general anesthesia combined with local anesthesia. Lidocaine with adrenaline is often used, but some uses longer acting substances like bupivacaine 2,5 mg/ml with adrenaline 5 microg/ml.

Adding of adrenaline prolongs the effect of anesthesia and the effect is probably strongest for short-acting local anesthetics. Adrenaline may delay absorption of local anesthetics avoiding toxic plasma concentrations and reduce local bleeding. Injection of local anesthetics with adrenaline may affect haemodynamic stability.

Para-cervical block has been used for analgesia in first stage of labor, but may give foetal bradycardia in 3-4 % and may affect the cardiotocogram in 10-12%. This effect is observed with bupivacaine and the less toxic levobupivacaine. Because of fear for complications and foetal injury this block has been replaced by more effective and safer methods like epidural and spinal anesthesia.

In gynecological practice the para-cervical block is still used for termination of pregnancy, cervical conization and for instrumentation of uterus.

We have observed affection of hemodynamic stability when using local anesthetics with adrenaline in nasal mucosa and during cervical conization. Some patients may experience increase or decrease in blood pressure and heart rate with a duration of 3-5 minutes.

Kerkkamp and coworkers have observed an 64% increase in cardiac output when using bupivacaine with adrenaline 100 microg epidurally but de Leeuw et al find an effect of less than 10% change in cardiac output during combined psoas compartment and ischiadic-block. We have performed a non-randomized, non-blinded pilot-study showing a 86% increase in systolic blood pressure and 65% increase in cardiac output after para-cervical block with bupivacaine 50 mg and adrenaline 100 microg. We want to confirm these results by doing a randomized, blinded study.

Most day-surgical patients are classified as ASA (American Society of Anesthesiologists) grade 1-2, and the complication rates are low. Still we may experience cardiovascular events during anesthesia with patients considered without cardiovascular diseases. Hemodynamic stability during anesthesia is a goal for all patients.

LiDCOplus (Lithium Dilution Cardiac Output) is a minimal invasive hemodynamic monitor for measuring cardiac output (CO) and systemic resistance (SVR). It uses two algorithms. PulseCO is an analysis of artery-waveform and gives nominal values. LiDCO is calibration with a small dose Lithium and gives absolute values. This study will examine relative changes, and calibration is not necessary.

The primary endpoints with respect to the hemodynamic effects of the interventions are group differences in systolic blood pressure and cardiac output the first 0-10 minutes after intervention. Secondary endpoints are other hemodynamic variables as stroke volume (SV), heart rate (HR), and systemic vascular resistance (SVR).

Demographic data and baseline measurements will be presented as mean (SD) if normally distributed or as median and range if not normally distributed, and group differences will be tested using the one-way ANOVA or Kruskal-Wallis tests, respectively. Baseline hemodynamic values represent measurements collected before administration of local anesthesia.

Being tested
Bupivacaine, Adrenaline
Keywords
Epinephrine, Bupivacaine, Stroke Volume, Cardiac Output, Heart Rate, Hemodynamics, Total Peripheral Resistance, Blood Pressure, Paracervical block, LiDCO, Adrenaline, Conization, PulsCO
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

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

  • BupivacaineDrug

    Also called Marcain

    Infiltration anesthesia

  • AdrenalineDrug

    Also called Epinephrine

    Infiltration anesthesia

Study groups in NCT02368054
Study groupRoleWhat they receive
Bupivacaine-adrenalineActive comparatorParacervical block. Bupivacaine 2,5 mg/ml Adrenaline 5 microg/ml; 20 ml
Receives: Drug: Bupivacaine; Drug: Adrenaline
BupivacaineActive comparatorParacervical block. Bupivacaine 2,5 mg/ml; 20 ml
Receives: Drug: Bupivacaine

What is being measured

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

  1. Changes in Cardiac Output as measured by LiDCOplus monitor.

    After paracervical Block.

    Measured: 0-10 minutes

Secondary outcomes (3)

  1. Changes in Stroke Volume as measured by LiDCOplus monitor.

    After paracervical block.

    Measured: 0-10 minutes

  2. Changes in Heart Rate as measured by LiDCOplus monitor.

    After paracervical block.

    Measured: 0-10 minutes

  3. Changes in Total Peripheral Resistance as measured by LiDCOplus monitor.

    After paracervical Block.

    Measured: 0-10 minutes

Timeline

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

  1. First posted20 Feb 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02368054
Sponsor's protocol ID
49024
Other IDs
2014-004504-29, 2014/1909/REK-vest, 2014
Acronym
HSBAPCB
Status last verified
Aug 2016
First submitted
9 Feb 2015
Last updated
19 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Nesheim BI. Which local anesthetic is best suited for paracervical blocks? Acta Obstet Gynecol Scand. 1983;62(3):261-4. doi: 10.3109/00016348309155804.

    PubMed 6353840

  • Panda N, Verma RK, Panda NK. Efficacy and safety of high-concentration adrenaline wicks during functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg. 2012 Apr;41(2):131-7.

    PubMed 22569014

  • Zhao F, Wang Z, Yang J, Sun J, Wang Q, Xu J. Low-dosage adrenaline induces transient marked decrease of blood pressure during functional endoscopic sinus surgery. Am J Rhinol. 2006 Mar-Apr;20(2):182-5.

    PubMed 16686385

  • Palomaki O, Huhtala H, Kirkinen P. A comparative study of the safety of 0.25% levobupivacaine and 0.25% racemic bupivacaine for paracervical block in the first stage of labor. Acta Obstet Gynecol Scand. 2005 Oct;84(10):956-61. doi: 10.1111/j.0001-6349.2005.00709.x.

    PubMed 16167911

  • Kerkkamp HE, Gielen MJ. Cardiovascular effects of epidural local anaesthetics. Comparison of 0.75% bupivacaine and 0.75% ropivacaine, both with adrenaline. Anaesthesia. 1991 May;46(5):361-5. doi: 10.1111/j.1365-2044.1991.tb09544.x.

    PubMed 2035780

  • de Leeuw MA, Slagt C, Hoeksema M, Zuurmond WW, Perez RS. Hemodynamic changes during a combined psoas compartment-sciatic nerve block for elective orthopedic surgery. Anesth Analg. 2011 Mar;112(3):719-24. doi: 10.1213/ANE.0b013e318206bc30. Epub 2010 Dec 14.

    PubMed 21156977

  • Sjoeen GH, Falk RS, Hauge TH, Langesaeter E. Haemodynamic stability after paracervical block: A randomized, controlled, double-blind study comparing bupivacaine-adrenaline with bupivacaine. Acta Anaesthesiol Scand. 2019 Mar;63(3):373-380. doi: 10.1111/aas.13259. Epub 2018 Sep 10.

    PubMed 30203440

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine and Adrenaline in people with Cervical Intraepithelial Neoplasia, run by Helse Fonna at 1 site in Norway.

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 1 inclusion and 11 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 19 Aug 2016. 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 Norway. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Changes in Cardiac Output as measured by LiDCOplus monitor. (time frame: 0-10 minutes). 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 NCT02368054, which also lists 7 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 19 Aug 2016.

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