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.

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Chirocaine %0.5; Drug: Chirocaine Heavy 40; Drug: Chirocaine Heavy 60; Drug: Chirocaine Heavy 80

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plain Levobupivacaine (Chirocaine (% 0.5); Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain	Drug: Chirocaine %0.5; Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl; Other Names: Group 1; Plain levobupivacaine
Active Comparator: Levobupivacaine (Chirocaine % 0,75) + dextrose 40; Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40	Drug: Chirocaine Heavy 40; Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl; Other Names: Group 2; levobupivacaine heavy 40
Active Comparator: Levobupivacaine (Chirocaine % 0,75) + dextrose 60; Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60	Drug: Chirocaine Heavy 60; Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl; Other Names: Group 3; levobupivacaine heavy 60
Active Comparator: Levobupivacaine (Chirocaine % 0,75) + dextrose 80; Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80	Drug: Chirocaine Heavy 80; Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl; Other Names: Group 4; levobupivacaine heavy 80

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Balikesir University
• Investigators: Study Director: Ozlem Sagir, Assist. Prof, Balikesir University School of Medicine Department of Anesthesia and Reanimation

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 14, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Cesarean Section; Levobupivacaine; Anesthesia, Spinal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: osagir2