Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in C/S
Condition: Health Care; Drugs
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with
      hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for
      analgesics in patients undergoing elective cesarean section. Our hypothesis is that
      hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic
      conditions compared to hyperbaric bupivacaine.
    

Detailed description: 
      Material - Method 60 patients, American Society of Anesthesiology (ASA) group I-II, between
      the ages of 18-45 who were scheduled for elective cesarian section under regional anesthesia
      are going to be included. Patients with contraindications to regional anesthesia, known
      allergy, suffering from pregnancy induced hypertension or placenta previa will be excluded
      from the study.

      Patients will not be premedicated. After routine monitorization , IV access and fluid
      replacement patients will be separated to two groups on a randomised manner. Under sterile
      conditions spinal anesthesia will be performed in the sitting position at the level L3-4 or L
      4-5 via epidural-spinal combined including a 27 G spinal needle.

      Group 1 will receive 8 mg hyperbaric bupivacaine plus 20 mcg fentanyl /2ml intrathecally.

      Group 2 will receive 8 mg hyperbaric levobupivacaine plus 20 mcg fentanyl/2ml intrathecally.

      The Hyperbaric form of Levobupivacaine is not available on market , so it will be prepared
      with the addition of % 30 dextrose by another anesthesiologist who will be blinded to the
      patients.

      Preparation: 2 ml of %0,75 levobupivacaine + 0,8 mL %30 dextrose + 0,2 mL of saline will be
      mixed. So it will contain 5 mg levobupivacaine and %8 dextrose per ml.

      Hypotension will be defined as a decrease in blood pressure more than % 30 percent of the
      basal measured systolic arterial pressure. Hypotension will be treated with 250 ml fast
      saline infusion and if no response with 5 mg of ephedrine IV. A heart rate under 50 beats/min
      will be defined as bradycardia and will be treated with 0.5 mg atropine i.v.. If the
      anesthesia is not sufficient 10 ml of % 0.25 levobupivacaine wil be administered through the
      epidural catheter. The level of sensory and motor block will be evaluated and recorded every
      3 minutes at the beginning and after 15 minutes it will be checked every 5 minutes until the
      end of surgery. Maximum level of sensory block, time to reach T4 dermatome and time to
      regression of 2 segments will be recorded. Nausea-vomiting, pruritus and shivering will also
      be recorded. Baby delivery time, which will be defined as the time from spinal medication to
      clamping of the umbilical cord will also be recorded. Total time of surgery will also be
      recorded. The time for the first analgesic requirement will be noticed as well. Patient and
      surgeon satisfaction will also be evaluated.
    

Intervention name(s): Hyperbaric levobupivacaine; Hyperbaric bupivacaine % 0.5
Intervention type(s): Drug; Drug
Other intervention name(s): Chirocaine %0.75; Marcaine heavy % 0.5
Intervention MeSH terms: Bupivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal anesthesia; cesarean section; hyperbaric levobupivacaine