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

NCT ID: NCT02430090

Last Updated: 2021-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-03-31

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.

Conditions

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Anesthesia

Keywords

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regionel anesthesia levobupivacaine ceserean section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Fentanyl

Intervention Type DRUG

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

Levobupivacaine

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

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

Levobupivacaine

Intervention Type DRUG

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

Interventions

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Levobupivacaine

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

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Sufentanil

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

Intervention Type DRUG

Levobupivacaine

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

Intervention Type DRUG

Levobupivacaine

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

Intervention Type DRUG

Other Intervention Names

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chirocaine sufenta chirocaine chirocaine

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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Müge Çakırca

Role: PRINCIPAL_INVESTIGATOR

Ankara Numune Training and Research hospital, Anesthesiology and Reanimation Clinic

References

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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.

Reference Type BACKGROUND
PMID: 12873927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14719424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10588555 (View on PubMed)

Other Identifiers

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2006-099

Identifier Type: -

Identifier Source: org_study_id