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AnesthesiaPhase 2NCT02430090

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

A Phase 2 study testing Levobupivacaine, Fentanyl and Sufentanil in people with Anesthesia, run by Ankara City Hospital Bilkent.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Anesthesia
What is being tested?
Levobupivacaine, Fentanyl and Sufentanil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Nov 2006to Mar 2007
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Multiple pregnancies,
  • preterm labor,
  • eclampsia,
  • preeclampsia,
  • concomitant diabetes mellitus,
  • allergy to local anesthetics, fentanyl or sufentanil,
  • contraindication for regional anesthesia were the exclusion criteria.

About this study

Official title: Comparison of Intratechal Low-Dose Levobupivacaine With Levobupivacaine-Fentanyl and Levobupivacaine-Sufentanil Combinations for Cesarean 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.

Read the 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.

Conditions
Anesthesia
Being tested
Levobupivacaine, Fentanyl, Sufentanil
Keywords
regionel anesthesia, levobupivacaine, ceserean section

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevobupivacaineDrug

    Also called chirocaine

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

  • FentanylDrug

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

  • SufentanilDrug

    Also called sufenta

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

  • LevobupivacaineDrug

    Also called chirocaine

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

  • LevobupivacaineDrug

    Also called chirocaine

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

Study groups in NCT02430090
Study groupRoleWhat they receive
LevobupivacaineExperimentalLevobupivacaine, 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
Receives: Drug: Levobupivacaine
Levobupivacaine + fentanylExperimentalFentanyl - 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
Receives: Drug: Fentanyl; Drug: Levobupivacaine
Levobupivacaine + sufentanilExperimentalSufentanil 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
Receives: Drug: Sufentanil; Drug: Levobupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 4 months

Secondary outcomes (1)

  1. 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.

    Measured: Up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2015 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2007
  4. Study completionMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02430090
Sponsor's protocol ID
2006-099
Status last verified
May 2015
First submitted
20 Apr 2015
Last updated
19 Nov 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 12873927

  • 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.

    PubMed 14719424

  • 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.

    PubMed 10588555

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Levobupivacaine, Fentanyl and Sufentanil in people with Anesthesia, run by Ankara City Hospital Bilkent.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02430090, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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