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Completed

NCT Number: NCT03956303

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

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

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Key information

Conditions

Anesthesia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chirocaine %0.5

Drug

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

Other names: Plain levobupivacaine, Group 1

Chirocaine Heavy 40

Drug

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

Other names: levobupivacaine heavy 40, Group 2

Chirocaine Heavy 60

Drug

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

Other names: levobupivacaine heavy 60, Group 3

Chirocaine Heavy 80

Drug

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

Other names: levobupivacaine heavy 80, Group 4

Primary outcomes

  1. Change of time to reach T10 sensory spinal block level at intraoperative period by pinprick test

    Time frame: 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.

    time to reach T10 sensory block by pinprick test

  2. Spinal Block Quality by questioning

    Time frame: At the end of surgery

    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.

  3. Change the sensory block level at intraoperative period by pinprick test

    Time frame: 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

    the level of maximum sensory block by pinprick test

  4. time to reach maximum level of sensory block at intraoperative period by pinprick test

    Time frame: 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.

    time to reach maximum level of sensory block by pinprick test

  5. Change over time at the level of sensory block at intraoperative period by pinprick test

    Time frame: 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.

    time to two segment regression of maximum sensory block by pinprick test

  6. Change in motor block level from PACU to discharge

    Time frame: every 15 minutes until end of surgery and 30 minutes postoperatively up to 2 hours by Bromage Scale

    motor block recovery time by bromage scale

  7. Change to regression of sensory block by pinprick test

    Time frame: In the postoperative period, changes in sensory block level will be recorded at 30 min intervals up to 2 hours

    time to S2 regression of sensory block by pinprick test

Secondary outcomes

  1. Haemodynamic evaluation by mmHg for systolic , diastolic and mean arterial blood pressure

    Time frame: 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

    measurement of systolic , diastolic and mean arterial blood pressure

  2. Number of participants with postoperative complications ( head ache, back pain, numbness of lower extremity )by phone

    Time frame: on postoperative day 3 by phone.

    postoperative complications ( head ache, back pain, numbness of lower extremity )by phone

  3. evaluation of umbilical vein blood gas analysis

    Time frame: immediately after fetus delivery

    umbilical vein blood sample will be obtained immediately after delivery of the fetus and will a blood gas analysis will be performed

Sponsors and collaborators

Lead sponsor

Balikesir University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 20, 2019
Registry last updated
May 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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