Clinical trial NCT03956303: Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.
Official title: Comparison of the Efficacy of 3 Different Density Levobupivacaine Solutions + Fentanyl Applied Intrathecally for Spinal Anesthesia in Caesarean Delivery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Anesthesia, Spinal
Cesarean Section
Levobupivacaine
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change of time to reach T10 sensory spinal block level at intraoperative period by pinprick test
timeFrame: 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.
measure: Spinal Block Quality by questioning
timeFrame: At the end of surgery
measure: Change the sensory block level at intraoperative period by pinprick test
timeFrame: 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
measure: time to reach maximum level of sensory block at intraoperative period by pinprick test
timeFrame: 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.
measure: Change over time at the level of sensory block at intraoperative period by pinprick test
timeFrame: 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.
measure: Change in motor block level from PACU to discharge
timeFrame: every 15 minutes until end of surgery and 30 minutes postoperatively up to 2 hours by Bromage Scale
measure: Change to regression of sensory block by pinprick test
timeFrame: In the postoperative period, changes in sensory block level will be recorded at 30 min intervals up to 2 hours
Secondary outcomes:
measure: Haemodynamic evaluation by mmHg for systolic , diastolic and mean arterial blood pressure
timeFrame: 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
measure: Number of participants with postoperative complications ( head ache, back pain, numbness of lower extremity )by phone
timeFrame: on postoperative day 3 by phone.
measure: evaluation of umbilical vein blood gas analysis
timeFrame: immediately after fetus delivery
Other outcomes:
Locations:
Study officials:
affiliation: Balikesir University School of Medicine Department of Anesthesia and Reanimation
name: Ozlem Sagir, Assist. Prof
role: STUDY_DIRECTOR
References: