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

NCT02430090 | Completed Phase 2 Results

• 1 other identifier: 2006-099
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Keywords

regionel anesthesia; levobupivacaine; ceserean section

Outcome Measures

Primary Outcomes (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.

  Up to 4 months

Secondary Outcomes (1)

• Number of Participants With Pain Scores on the Visual Analog Scale

  Up to 4 months

Study Arms (3)

Levobupivacaine

EXPERIMENTAL

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

Levobupivacaine + fentanyl

EXPERIMENTAL

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; Drug: Levobupivacaine

Levobupivacaine + sufentanil

EXPERIMENTAL

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; Drug: Levobupivacaine

Interventions

Levobupivacaine DRUG

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

Also known as: chirocaine

Levobupivacaine

Fentanyl DRUG

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

Levobupivacaine + fentanyl

Sufentanil DRUG

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

Also known as: sufenta

Levobupivacaine + sufentanil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Multiple pregnancies,
• preterm labor,
• eclampsia,
• preeclampsia,
• concomitant diabetes mellitus,
• allergy to local anesthetics, fentanyl or sufentanil,

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Related Publications (3)

• 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.

  PMID: 12873927 BACKGROUND

• 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.

  PMID: 14719424 BACKGROUND

• 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.

  PMID: 10588555 BACKGROUND

MeSH Terms

Interventions

Levobupivacaine; Fentanyl; Sufentanil

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

A limitation of this study is that the baricity of the local anaesthetic could have been affected as the fentanyl and sufentanil were diluted within a mixture. Using these opiods in undiluted form in future studies would remove this limitation.

Results Point of Contact

• Title: Dr. Müge Çakırca
• Organization: Ankara Numune Training and Research Hospital

mugeturkoglu81@hotmail.com

+905054433177

Study Officials

• Müge Çakırca

  Ankara Numune Training and Research hospital, Anesthesiology and Reanimation Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 30, 2015
• Study Start: November 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: November 19, 2021
• Results First Posted: June 10, 2015

Record last verified: 2015-05