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

Cervical Intraepithelial Neoplasia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368054
• Other study ID #: 49024
• Secondary ID: 2014-004504-2920
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2015
• Last updated: August 18, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: Helse Fonna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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 Because of fear for complications and foetal injury this block has been replaced by more effective and safer methods like epidural and spinal anesthesia.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia

Intervention

Drug:
• Bupivacaine
Infiltration anesthesia
• Adrenaline
Infiltration anesthesia

Locations

Country	Name	City	State
Norway	Kirurgisk Klinikk-Anestesi	Haugesund	Rogaland

Sponsors (1)

Lead Sponsor	Collaborator
Helse Fonna

Country where clinical trial is conducted

Norway, 

References & Publications (6)

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. — View 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. — View Citation

Nesheim BI. Which local anesthetic is best suited for paracervical blocks? Acta Obstet Gynecol Scand. 1983;62(3):261-4. — View Citation

Palomäki 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. — View 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. — View 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. Retraction in: Am J Rhinol. 2006 Nov-Dec;20(6):673. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Cardiac Output as measured by LiDCOplus monitor.	After paracervical Block.	0-10 minutes	Yes
Secondary	Changes in Stroke Volume as measured by LiDCOplus monitor.	After paracervical block.	0-10 minutes	Yes
Secondary	Changes in Heart Rate as measured by LiDCOplus monitor.	After paracervical block.	0-10 minutes	Yes
Secondary	Changes in Total Peripheral Resistance as measured by LiDCOplus monitor.	After paracervical Block.	0-10 minutes	Yes