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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

Tracking Information
First Submitted Date  ICMJE December 12, 2013
First Posted Date  ICMJE January 1, 2014
Last Update Posted Date May 16, 2019
Study Start Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2013)
evaluation of the changes in mean arterial blood pressure between two groups. [ Time Frame: 6 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2013)
Time to reach T4 dermatome [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in C/S
Official Title  ICMJE The Comparison of Hyperbaric Bupivacaine Plus Fentanyl and Hyperbaric Levobupivacaine Plus Fentanyl Administered Intrathecally in Patients Undergoing Elective Cesarean Section
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Health Care
  • Drugs
Intervention  ICMJE
  • Drug: Hyperbaric levobupivacaine
    Other Name: Chirocaine %0.75
  • Drug: Hyperbaric bupivacaine % 0.5
    Other Name: Marcaine heavy % 0.5
Study Arms  ICMJE
  • Experimental: Hyperbaric levobupivacaine
    Group 2 Hyperbaric levobupivacaine % 0.5 plus fentanyl; 2 ml total intrathecally
    Intervention: Drug: Hyperbaric levobupivacaine
  • Active Comparator: Hyperbaric bupivacaine
    Group 1 Hyperbaric bupivacaine % 0.5 plus fentanyl 2 ml intrathecally
    Intervention: Drug: Hyperbaric bupivacaine % 0.5
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 31, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02025374
Other Study ID Numbers  ICMJE osagir1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ozlem Sagir, MD, Balikesir University
Study Sponsor  ICMJE Balikesir University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Balikesir University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP