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

NCT02368054 | Completed Phase 4 DMC

• 3 other identifiers: 490242014-004504-292014/1909/REK-vest
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Epinephrine; Bupivacaine; Stroke Volume; Cardiac Output; Heart Rate; Hemodynamics; Total Peripheral Resistance; Blood Pressure; Paracervical block; LiDCO; Adrenaline; Conization; PulsCO

Outcome Measures

Primary Outcomes (1)

• Changes in Cardiac Output as measured by LiDCOplus monitor.

  After paracervical Block.

  0-10 minutes

Secondary Outcomes (3)

• Changes in Stroke Volume as measured by LiDCOplus monitor.

  0-10 minutes

• Changes in Heart Rate as measured by LiDCOplus monitor.

  0-10 minutes

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

  0-10 minutes

Study Arms (2)

Bupivacaine-adrenaline

ACTIVE COMPARATOR

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

Drug: Bupivacaine; Drug: Adrenaline

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Infiltration anesthesia

Also known as: Marcain

Bupivacaine; Bupivacaine-adrenaline

Adrenaline DRUG

Infiltration anesthesia

Also known as: Epinephrine

Bupivacaine-adrenaline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of cervical pre-cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Fonna: lead

Study Sites (1)

Kirurgisk Klinikk-Anestesi

Haugesund, Rogaland, 5504, Norway

Location

Related Publications (7)

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

  PMID: 6353840 BACKGROUND

• 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.

  PMID: 22569014 BACKGROUND

• 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.

  PMID: 16686385 BACKGROUND

• 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.

  PMID: 16167911 BACKGROUND

• 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.

  PMID: 2035780 BACKGROUND

• 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.

  PMID: 21156977 BACKGROUND

• 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.

  PMID: 30203440 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Bupivacaine; Epinephrine

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Gunnar Helge Sjøen, MD

  Helse Fonna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 20, 2015
• Study Start: May 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

NO (1)