Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 4

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      foetal injury this block has been replaced by more effective and safer methods like epidural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.
    

Intervention name(s): Bupivacaine; Adrenaline
Intervention type(s): Drug; Drug
Intervention description(s): Infiltration anesthesia; Infiltration anesthesia
Other intervention name(s): Marcain; Epinephrine
Intervention MeSH terms: Epinephrine; Racepinephrine; Bupivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epinephrine; Bupivacaine; Stroke Volume; Cardiac Output; Heart Rate; Hemodynamics; Total Peripheral Resistance; Blood Pressure; Paracervical block; LiDCO; Adrenaline; Conization; PulsCO