Brief Title
Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization
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
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foetal injury this block has been replaced by more effective and safer methods like epidural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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Changes in Cardiac Output as measured by LiDCOplus monitor.
Secondary Outcome
Changes in Stroke Volume as measured by LiDCOplus monitor.
Condition
Cervical Intraepithelial Neoplasia
Intervention
Bupivacaine
Study Arms / Comparison Groups
Bupivacaine-adrenaline
Description: Paracervical block. Bupivacaine 2,5 mg/ml Adrenaline 5 microg/ml; 20 ml
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
34
Start Date
May 2015
Completion Date
February 2016
Primary Completion Date
February 2016
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
Gender
Female
Ages
18 Years - 50 Years
Accepts Healthy Volunteers
No
Contacts
Gunnar Helge Sjøen, MD, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT02368054
Organization ID
49024
Secondary IDs
2014-004504-29
Responsible Party
Principal Investigator
Study Sponsor
Helse Fonna
Study Sponsor
Gunnar Helge Sjøen, MD, Principal Investigator, Helse Fonna
Verification Date
August 2016