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Completed

NCT Number: NCT02430090

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Levobupivacaine

Drug

this used in intratechal area and for spinal anesthesia in ceserean section

Other names: chirocaine

Fentanyl

Drug

this used in intratechal area and for spinal anesthesia in ceserean section

Sufentanil

Drug

this used in intratechal area and for spinal anesthesia in ceserean section

Other names: sufenta

Primary outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: Up to 4 months

    The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.

Secondary outcomes

  1. Number of Participants With Pain Scores on the Visual Analog Scale

    Time frame: Up to 4 months

    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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 30, 2015
Registry last updated
Nov 19, 2021

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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