Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.
NCT ID: NCT03956303
Last Updated: 2019-05-20
Study Results
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Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2014-06-30
2016-08-31
Brief Summary
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Detailed Description
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Group 1: Levobupivacaine 8 mg + 20 mcg Fentanyl Group 2: Levobupivacaine 8 mg + 20 mcg Fentanyl + 40 mg Dextrose Group 3: Levobupivacaine 8 mg + 20 mcg Fentanyl + 60 mg Dextrose Group 4: Levobupivacaine 8 mg + 20 mcg Fentanyl + 80 mg Dextrose After anesthesia induction motor block was evaluated via bromage scale and sensory block via pinprick test every 3 minutes for the first 15 minutes, and every 5 minutes up to 60 minutes. Maximum sensory block level, time to reach maximum block level, time needed to achieve T10 sensory level were recorded.
Baby delivery time, and operation duration were also recorded. Time to two segment regression of maximum sensory block, motor block recovery time and time to S2 regression of sensory block will be recorded.
Hemodynamic data, nausea vomiting, were also recorded throughout surgery at the same evaluation periods and postoperative period.
The surgeon will also evaluate the abdominal relaxation surgical block quality as good, medium and poor.
The patient will evaluate spinal block analgesia quality as good, medium or poor.
Pain scores are going to be evaluated by VAS at the beginning, uterine incision and during abdominal closure. Time for first analgesic requirement and postoperative pain is also going to be evaluated by VAS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Plain Levobupivacaine (Chirocaine (% 0.5)
Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain
Chirocaine %0.5
Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl
Levobupivacaine (Chirocaine % 0,75) + dextrose 40
Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40
Chirocaine Heavy 40
Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl
Levobupivacaine (Chirocaine % 0,75) + dextrose 60
Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60
Chirocaine Heavy 60
Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl
Levobupivacaine (Chirocaine % 0,75) + dextrose 80
Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80
Chirocaine Heavy 80
Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl
Interventions
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Chirocaine %0.5
Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl
Chirocaine Heavy 40
Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl
Chirocaine Heavy 60
Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl
Chirocaine Heavy 80
Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pregnancy at Term
* Scheduled for elective caesarean delivery
Exclusion Criteria
* drug allergy
* pregnancy related disorders (hypertension, placenta previa, fetal problems)
18 Years
45 Years
FEMALE
Yes
Sponsors
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Balikesir University
OTHER
Responsible Party
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Ozlem Sagir, MD
Associated Professor
Principal Investigators
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Ozlem Sagir, Assist. Prof
Role: STUDY_DIRECTOR
Balikesir University School of Medicine Department of Anesthesia and Reanimation
Other Identifiers
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osagir2
Identifier Type: -
Identifier Source: org_study_id
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