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Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in C/S

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02025374
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ozlem Sagir, MD, Balikesir University

Brief 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.

Condition or disease Intervention/treatment Phase
Health Care Drugs Drug: Hyperbaric levobupivacaine Drug: Hyperbaric bupivacaine % 0.5 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. evaluation of the changes in mean arterial blood pressure between two groups. [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Time to reach T4 dermatome [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Locations
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Turkey
Balıkesir University Faculty of Medicine
Balıkesir, Turkey, 10145
Sponsors and Collaborators
Balikesir University

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Responsible Party: Ozlem Sagir, MD, Assistant Professor, Balikesir University
ClinicalTrials.gov Identifier: NCT02025374    
Other Study ID Numbers: osagir1
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Keywords provided by Ozlem Sagir, MD, Balikesir University:
spinal anesthesia
cesarean section
hyperbaric levobupivacaine
Additional relevant MeSH terms:
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Fentanyl
Bupivacaine
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General