Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in C/S

Health Care Clinical Trial

Official title:

The Comparison of Hyperbaric Bupivacaine Plus Fentanyl and Hyperbaric Levobupivacaine Plus Fentanyl Administered Intrathecally in Patients Undergoing Elective Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025374
• Other study ID #: osagir1
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: August 2016

Study information

• Verified date: May 2019
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

elective cesarean section no other coexisting medical situation

Exclusion Criteria:

known contraindication to regional anesthesia coexisting pregnancy induced problem placental mislocation known allergy

Related Conditions & MeSH terms

• Drugs
• Health Care

Intervention

Drug:
• Hyperbaric levobupivacaine

• Hyperbaric bupivacaine % 0.5

Locations

Country	Name	City	State
Turkey	Balikesir University Faculty of Medicine	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of the changes in mean arterial blood pressure between two groups.		6 month
Secondary	Time to reach T4 dermatome		6 months