NCT03956303

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Balikesir University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Chirocaine %0.5	Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl
DRUG	Chirocaine Heavy 40	Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl
DRUG	Chirocaine Heavy 60	Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl
DRUG	Chirocaine Heavy 80	Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-06-01
• Completion: 2016-08-01
• First posted: 2019-05-20
• Last updated: 2019-05-20