Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.

Study Overview
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Brief Summary
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The investigator's aim is to compare the efficacy of 3 levobupivacaine solutions with different density on spinal anesthesia for caesarean delivery.

Detailed Description
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Patients scheduled for elective caesarean delivery were separated into 4 groups. Spinal anesthesia was performed with one of the following regimens. 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.

Official Title
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Comparison of the Efficacy of 3 Different Density Levobupivacaine Solutions + Fentanyl Applied Intrathecally for Spinal Anesthesia in Caesarean Delivery.

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Chirocaine %0.5
* Drug: Chirocaine Heavy 40
* Drug: Chirocaine Heavy 60
* Drug: Chirocaine Heavy 80


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II Pregnancy at Term Scheduled for elective caesarean delivery Exclusion Criteria: contraindication for spinal anesthesia drug allergy pregnancy related disorders (hypertension, placenta previa, fetal problems)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plain Levobupivacaine (Chirocaine (% 0.5)<br>Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain | Drug: Chirocaine %0.5<br>* Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl<br>* Other names: Group 1;|
| Active Comparator: Levobupivacaine (Chirocaine % 0,75) + dextrose 40<br>Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40 | Drug: Chirocaine Heavy 40<br>* Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl<br>* Other names: Group 2;|
| Active Comparator: Levobupivacaine (Chirocaine % 0,75) + dextrose 60<br>Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60 | Drug: Chirocaine Heavy 60<br>* Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl<br>* Other names: Group 3;|
| Active Comparator: Levobupivacaine (Chirocaine % 0,75) + dextrose 80<br>Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80 | Drug: Chirocaine Heavy 80<br>* Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl<br>* Other names: Group 4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of time to reach T10 sensory spinal block level at intraoperative period by pinprick test | time to reach T10 sensory block by pinprick test | Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia.In these evaluation periods, the sensory block will be recorded when the T10 is detected. | 
| Spinal Block Quality by questioning | the intensity of spinal block will be evaluated via questioning the surgeon and the patient. the surgeon will grade the abdominal relaxivity as good, medium or poor The patient will evaluate spinal block analgesia quality as good, medium or poor. | At the end of surgery | 
| Change the sensory block level at intraoperative period by pinprick test | the level of maximum sensory block by pinprick test | Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The highest measured level by pinprick test be recorded | 
| time to reach maximum level of sensory block at intraoperative period by pinprick test | time to reach maximum level of sensory block by pinprick test | Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. the time to reach the highest measured by pinprick test will be recorded. | 
| Change over time at the level of sensory block at intraoperative period by pinprick test | time to two segment regression of maximum sensory block by pinprick test | Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The time to two segment regression of maximum sensory block by pinprick test will be recorded. | 
| Change in motor block level from PACU to discharge | motor block recovery time by bromage scale | every 15 minutes until end of surgery and 30 minutes postoperatively up to 2 hours by Bromage Scale | 
| Change to regression of sensory block by pinprick test | time to S2 regression of sensory block by pinprick test | In the postoperative period, changes in sensory block level will be recorded at 30 min intervals up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemodynamic evaluation by mmHg for systolic , diastolic and mean arterial blood pressure | measurement of systolic , diastolic and mean arterial blood pressure | Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. every 30 minutes up to 2 hours | 
| Number of participants with postoperative complications ( head ache, back pain, numbness of lower extremity )by phone | postoperative complications ( head ache, back pain, numbness of lower extremity )by phone | on postoperative day 3 by phone. | 
| evaluation of umbilical vein blood gas analysis | umbilical vein blood sample will be obtained immediately after delivery of the fetus and will a blood gas analysis will be performed | immediately after fetus delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Spinal, Cesarean Section, Levobupivacaine