Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section

Anesthesia Clinical Trial

Official title:

Comparison of Intratechal Low-Dose Levobupivacaine With Levobupivacaine-Fentanyl and Levobupivacaine-Sufentanil Combinations for Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430090
• Other study ID #: 2006-099
• Status: Completed
• Phase: Phase 2
• Start date: November 2006
• Est. completion date: March 2007

Study information

• Verified date: May 2015
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Levobupivacaine
this used in intratechal area and for spinal anesthesia in ceserean section
• Fentanyl
this used in intratechal area and for spinal anesthesia in ceserean section
• Sufentanil
this used in intratechal area and for spinal anesthesia in ceserean section
• Levobupivacaine
this used in intratechal area and for spinal anesthesia in ceserean section
• Levobupivacaine
this used in intratechal area and for spinal anesthesia in ceserean section

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.	Up to 4 months
Secondary	Number of Participants With Pain Scores on the Visual Analog Scale	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 were recorded.	Up to 4 months