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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Fentanyl
* Drug: Sufentanil
* Drug: Levobupivacaine
* Drug: Levobupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levobupivacaine<br>Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. Injection Surgical anaesthesia Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T | Drug: Levobupivacaine<br>* this used in intratechal area and for spinal anesthesia in ceserean section<br>* Other names: chirocaine;|
| Experimental: Levobupivacaine + fentanyl<br>Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain. Indications: Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response. Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL | Drug: Fentanyl<br>* this used in intratechal area and for spinal anesthesia in ceserean section<br>Drug: Levobupivacaine<br>* this used in intratechal area and for spinal anesthesia in ceserean section<br>* Other names: chirocaine;|
| Experimental: Levobupivacaine + sufentanil<br>Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation. Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg. Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx | Drug: Sufentanil<br>* this used in intratechal area and for spinal anesthesia in ceserean section<br>* Other names: sufenta;Drug: Levobupivacaine<br>* this used in intratechal area and for spinal anesthesia in ceserean section<br>* Other names: chirocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regionel anesthesia, levobupivacaine, ceserean section