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

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Bupivacaine
Adrenaline
Sponsored by
Helse Fonna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring Epinephrine, Bupivacaine, Stroke Volume, Cardiac Output, Heart Rate, Hemodynamics, Total Peripheral Resistance, Blood Pressure, Paracervical block, LiDCO, Adrenaline, Conization, PulsCO

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

• Clinical diagnosis of cervical pre-cancer

Exclusion Criteria:

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

Sites / Locations

  • Kirurgisk Klinikk-Anestesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bupivacaine-adrenaline

Bupivacaine

Arm Description

Paracervical block. Bupivacaine 2,5 mg/ml Adrenaline 5 microg/ml; 20 ml

Paracervical block. Bupivacaine 2,5 mg/ml; 20 ml

Outcomes

Primary Outcome Measures

Changes in Cardiac Output as measured by LiDCOplus monitor.
After paracervical Block.

Secondary Outcome Measures

Changes in Stroke Volume as measured by LiDCOplus monitor.
After paracervical block.
Changes in Heart Rate as measured by LiDCOplus monitor.
After paracervical block.
Changes in Total Peripheral Resistance as measured by LiDCOplus monitor.
After paracervical Block.

Full Information

First Posted
February 9, 2015
Last Updated
August 18, 2016
Sponsor
Helse Fonna
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1. Study Identification

Unique Protocol Identification Number
NCT02368054
Brief Title
Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization
Acronym
HSBAPCB
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helse Fonna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. Adrenaline might reduce local bleeding and reduce toxicity of bupivacaine by reducing absorption, but might affect cardiovascular function. This study will examine this effect.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia
Keywords
Epinephrine, Bupivacaine, Stroke Volume, Cardiac Output, Heart Rate, Hemodynamics, Total Peripheral Resistance, Blood Pressure, Paracervical block, LiDCO, Adrenaline, Conization, PulsCO

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine-adrenaline
Arm Type
Active Comparator
Arm Description
Paracervical block. Bupivacaine 2,5 mg/ml Adrenaline 5 microg/ml; 20 ml
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Paracervical block. Bupivacaine 2,5 mg/ml; 20 ml
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcain
Intervention Description
Infiltration anesthesia
Intervention Type
Drug
Intervention Name(s)
Adrenaline
Other Intervention Name(s)
Epinephrine
Intervention Description
Infiltration anesthesia
Primary Outcome Measure Information:
Title
Changes in Cardiac Output as measured by LiDCOplus monitor.
Description
After paracervical Block.
Time Frame
0-10 minutes
Secondary Outcome Measure Information:
Title
Changes in Stroke Volume as measured by LiDCOplus monitor.
Description
After paracervical block.
Time Frame
0-10 minutes
Title
Changes in Heart Rate as measured by LiDCOplus monitor.
Description
After paracervical block.
Time Frame
0-10 minutes
Title
Changes in Total Peripheral Resistance as measured by LiDCOplus monitor.
Description
After paracervical Block.
Time Frame
0-10 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Clinical diagnosis of cervical pre-cancer Exclusion Criteria: Pregnancy Feeding mother Bad nutritional state Infection Treatment for hypertension Diabetes for many years or complications Cardiovascular disease Serious anemia Cardial arrythmia Serious liver-disease Hypersensitivity to local anesthesia of amide-type
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Helge Sjøen, MD
Organizational Affiliation
Helse Fonna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kirurgisk Klinikk-Anestesi
City
Haugesund
State/Province
Rogaland
ZIP/Postal Code
5504
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
6353840
Citation
Nesheim BI. Which local anesthetic is best suited for paracervical blocks? Acta Obstet Gynecol Scand. 1983;62(3):261-4. doi: 10.3109/00016348309155804.
Results Reference
background
PubMed Identifier
22569014
Citation
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.
Results Reference
background
PubMed Identifier
16686385
Citation
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.
Results Reference
background
PubMed Identifier
16167911
Citation
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.
Results Reference
background
PubMed Identifier
2035780
Citation
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.
Results Reference
background
PubMed Identifier
21156977
Citation
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.
Results Reference
background
PubMed Identifier
30203440
Citation
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.
Results Reference
derived

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

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