Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in C/S
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|ClinicalTrials.gov Identifier: NCT02025374|
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Health Care Drugs||Drug: Hyperbaric levobupivacaine Drug: Hyperbaric bupivacaine % 0.5||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Comparison of Hyperbaric Bupivacaine Plus Fentanyl and Hyperbaric Levobupivacaine Plus Fentanyl Administered Intrathecally in Patients Undergoing Elective Cesarean Section|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2016|
Experimental: Hyperbaric levobupivacaine
Group 2 Hyperbaric levobupivacaine % 0.5 plus fentanyl; 2 ml total intrathecally
Drug: Hyperbaric levobupivacaine
Other Name: Chirocaine %0.75
Active Comparator: Hyperbaric bupivacaine
Group 1 Hyperbaric bupivacaine % 0.5 plus fentanyl 2 ml intrathecally
Drug: Hyperbaric bupivacaine % 0.5
Other Name: Marcaine heavy % 0.5
- evaluation of the changes in mean arterial blood pressure between two groups. [ Time Frame: 6 month ]
- Time to reach T4 dermatome [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025374
|Balıkesir University Faculty of Medicine|
|Balıkesir, Turkey, 10145|