The effects of local anesthesia with or without adrenaline on heart and circulation, for cervical conisation.

"Haemodynamic stability of bupivacaine with and without adrenaline for paracervical block during general anesthesia. A randomized controlled double blinded study."

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004504-29-NO

Enrollment

Registered

2014-10-31

Start date

2015-02-25

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical conisation is done for pre-cancer disease. The procedure is done 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.

Interventions

Trade Name: Marcain-Adrenalin Product Name: Marcain-Adrenalin Pharmaceutical Form: Injection Trade Name: Marcain Product Name: Marcain Pharmaceutical Form: Injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women with cervical pre-cancer. Age 18-50. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 or kidney disease Hypersensitivity to local anesthesia of amide-type Hypersensitivity to E 223

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Secondary end points are change in heart rate, stroke volume and total periferal volume.;Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated 0-10 minutes after paracervical block.	—

Primary

Measure	Time frame
Main Objective: The objective of the trial is to examine if bupivacaine with adrenaline gives a significant change in blood pressure and cardiac output haemodynamic parameters compared to bupivacaine without adrenaline.;Secondary Objective: Secondary objectives of the trial is to examine the effects on heart rate and stroke volume compared to cardiac output. ;Primary end point(s): Primary end point is increase in blood pressure and cardiac output. An increase of mean 25% is considered relevant.;Timepoint(s) of evaluation of this end point: The end points will be evaluated the first 0-10 minutes after paracervical block.	—

Measure

Time frame

Main Objective: The objective of the trial is to examine if bupivacaine with adrenaline gives a significant change in blood pressure and cardiac output haemodynamic parameters compared to bupivacaine without adrenaline.;Secondary Objective: Secondary objectives of the trial is to examine the effects on heart rate and stroke volume compared to cardiac output. ;Primary end point(s): Primary end point is increase in blood pressure and cardiac output. An increase of mean 25% is considered relevant.;Timepoint(s) of evaluation of this end point: The end points will be evaluated the first 0-10 minutes after paracervical block.

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Countries

Norway

Contacts

Public ContactForskningsavdelingen

Helse Fonna, Haugesund Sykehus

haldis.okland.lier@helse-fonna.no+4752732000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026