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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956303
• Other study ID #: osagir2
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: August 2016

Study information

• Verified date: May 2019
• Source: Balikesir University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Balikesir University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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
Primary	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	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
Secondary	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.
Secondary	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