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

NCT03956303 | Completed Phase 4

• 1 other identifier: osagir2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Anesthesia

Keywords

Anesthesia, Spinal; Cesarean Section; Levobupivacaine

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Haemodynamic evaluation by mmHg for 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

  on postoperative day 3 by phone.

• evaluation of umbilical vein blood gas analysis

  immediately after fetus delivery

Study Arms (4)

Plain Levobupivacaine (Chirocaine (% 0.5)

ACTIVE COMPARATOR

Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain

Drug: Chirocaine %0.5

Levobupivacaine (Chirocaine % 0,75) + dextrose 40

ACTIVE COMPARATOR

Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40

Drug: Chirocaine Heavy 40

Levobupivacaine (Chirocaine % 0,75) + dextrose 60

ACTIVE COMPARATOR

Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60

Drug: Chirocaine Heavy 60

Levobupivacaine (Chirocaine % 0,75) + dextrose 80

ACTIVE COMPARATOR

Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80

Drug: Chirocaine Heavy 80

Interventions

Chirocaine %0.5 DRUG

Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl

Also known as: Plain levobupivacaine, Group 1

Plain Levobupivacaine (Chirocaine (% 0.5)

Chirocaine Heavy 40 DRUG

Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl

Also known as: levobupivacaine heavy 40, Group 2

Levobupivacaine (Chirocaine % 0,75) + dextrose 40

Chirocaine Heavy 60 DRUG

Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl

Also known as: levobupivacaine heavy 60, Group 3

Levobupivacaine (Chirocaine % 0,75) + dextrose 60

Chirocaine Heavy 80 DRUG

Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl

Also known as: levobupivacaine heavy 80, Group 4

Levobupivacaine (Chirocaine % 0,75) + dextrose 80

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-II
• Pregnancy at Term
• Scheduled for elective caesarean delivery

You may not qualify if:

• contraindication for spinal anesthesia
• drug allergy
• pregnancy related disorders (hypertension, placenta previa, fetal problems)

Sponsors & Collaborators

• Balikesir University: lead

Study Officials

• Ozlem Sagir, Assist. Prof

  Balikesir University School of Medicine Department of Anesthesia and Reanimation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 20, 2019
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 20, 2019

Record last verified: 2019-05