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

August 18, 2016 updated by: Gunnar Helge Sjøen, Helse Fonna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Because of fear for complications and foetal injury this block has been replaced by more effective and safer methods like epidural and spinal anesthesia.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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Rogaland
      • Haugesund, Rogaland, Norway, 5504
        • Kirurgisk Klinikk-Anestesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine-adrenaline
Paracervical block. Bupivacaine 2,5 mg/ml Adrenaline 5 microg/ml; 20 ml
Drug: Bupivacaine
Infiltration anesthesia
Other Names:
  • Marcain
Drug: Adrenaline
Infiltration anesthesia
Other Names:
  • Epinephrine
Active Comparator: Bupivacaine
Paracervical block. Bupivacaine 2,5 mg/ml; 20 ml
Drug: Bupivacaine
Infiltration anesthesia
Other Names:
  • Marcain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Cardiac Output as measured by LiDCOplus monitor.
Time Frame: 0-10 minutes
After paracervical Block.
0-10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Stroke Volume as measured by LiDCOplus monitor.
Time Frame: 0-10 minutes
After paracervical block.
0-10 minutes
Changes in Heart Rate as measured by LiDCOplus monitor.
Time Frame: 0-10 minutes
After paracervical block.
0-10 minutes
Changes in Total Peripheral Resistance as measured by LiDCOplus monitor.
Time Frame: 0-10 minutes
After paracervical Block.
0-10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Fonna

Investigators

  • Principal Investigator: Gunnar Helge Sjøen, MD, Helse Fonna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49024
  • 2014-004504-29 (EudraCT Number)
  • 2014/1909/REK-vest (Other Identifier: Regional Ethical Comittee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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