Clinical trial NCT02430090: Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section
Official title: Comparison of Intratechal Low-Dose Levobupivacaine With Levobupivacaine-Fentanyl and Levobupivacaine-Sufentanil Combinations for Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia
Keywords: regionel anesthesia
levobupivacaine
ceserean section
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 45
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: 45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement and adverse effects were recorded.

Detailed description: 45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. Using CSE technique, 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement and adverse effects were recorded.

Eligibility criteria: Inclusion Criteria:

* pregnant women with a single live fetus aged 18-45 years old and classified as ASA I, undergoing elective cesarean section, were included the study in november 2006 to march 2007

Exclusion Criteria:

* Multiple pregnancies,
* preterm labor,
* eclampsia,
* preeclampsia,
* concomitant diabetes mellitus,
* allergy to local anesthetics, fentanyl or sufentanil,
* contraindication for regional anesthesia were the exclusion criteria.

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 4 months
Secondary outcomes:
measure: Number of Participants With Pain Scores on the Visual Analog Scale
timeFrame: Up to 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Numune Training and Research hospital, Anesthesiology and Reanimation Clinic
name: Müge Çakırca
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart J, Kellett N, Castro D. The central nervous system and cardiovascular effects of levobupivacaine and ropivacaine in healthy volunteers. Anesth Analg. 2003 Aug;97(2):412-416. doi: 10.1213/01.ANE.0000069506.68137.F2.
citation: Lee YY, Muchhal K, Chan CK. Levobupivacaine versus racemic bupivacaine in spinal anaesthesia for urological surgery. Anaesth Intensive Care. 2003 Dec;31(6):637-41. doi: 10.1177/0310057X0303100604.
citation: Burke D, Kennedy S, Bannister J. Spinal anesthesia with 0.5% S(-)-bupivacaine for elective lower limb surgery. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):519-23. doi: 10.1016/s1098-7339(99)90042-1.