Anesthesia
Conditions
Keywords
regionel anesthesia, levobupivacaine, ceserean section
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.
Interventions
DRUGLevobupivacaine
this used in intratechal area and for spinal anesthesia in ceserean section
DRUGFentanyl
this used in intratechal area and for spinal anesthesia in ceserean section
DRUGSufentanil
this used in intratechal area and for spinal anesthesia in ceserean section
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pain Scores on the Visual Analog Scale | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Levobupivacaine 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
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section | 15 |
| Levobupivacaine + Fentanyl 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
Fentanyl: 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 | 15 |
| Levobupivacaine + Sufentanil 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
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 | 15 |
| Total | 45 |
Baseline characteristics
| Characteristic | Levobupivacaine | Total | Levobupivacaine + Sufentanil | Levobupivacaine + Fentanyl |
|---|---|---|---|---|
| Age, Continuous | 27.8 years STANDARD_DEVIATION 7.4 | 26.9 years STANDARD_DEVIATION 7.5 | 27.4 years STANDARD_DEVIATION 7.1 | 25.5 years STANDARD_DEVIATION 5.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 45 Participants | 15 Participants | 15 Participants |
| Region of Enrollment Turkey | 15 participants | 45 participants | 15 participants | 15 participants |
| Sex: Female, Male Female | 15 Participants | 45 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 15 | 10 / 15 | 12 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: Up to 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Levobupivacaine | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 5 participants |
| Levobupivacaine + Fentanyl | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 10 participants |
| Levobupivacaine + Sufentanil | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 9 participants |
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.
Time frame: Up to 4 months