NCT01303731

Brief Summary

The objectives of this study is to test a combination of low dose local anesthetic Bupivacaine diluted in patient's CSF with lipophilic opiate Fentanyl for optimal spinal anesthesia during Cesarean Section. The dilution of Bupivacaine with CSF in our study would result in effective spinal anesthesia with relatively limited motor block, quick recovery of motor function and relatively long lasting analgesia. We expect lower incidence of side effects with this combination than with convenient dose of Bupivacaine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 25, 2011

Status Verified

January 1, 2011

Enrollment Period

11 months

First QC Date

January 20, 2011

Last Update Submit

February 23, 2011

Conditions

Cesarean SectionAnesthesia, SpinalLocal Anaesthetics Causing Adverse Effects in Therapeutic Use

Keywords

Spinal anesthesiaCesarean sectionMarcaine Spinal 0.5% Heavy minidoseFentanylLocal Anesthetics

Outcome Measures

Primary Outcomes (1)

  • prominence of motor blockade

    At the begining of the surgery and at the entry of the patients to PACU motor block will be evaluated

    up to 2 h

Secondary Outcomes (4)

  • operative condition

    up to 1 h

  • intraoperative hypotension

    up to 1 h

  • need for postoperative pain medication

    up to 2 h

  • general patient satisfaction

    after 24 h

Study Arms (2)

Standard dose Marcaine Spinal 0.5% Heavy

ACTIVE COMPARATOR

Standard group - will receive spinal anesthesia induced by Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml).

Drug: Bupivacaine

Minidose of Marcaine Spinal 0.5% Heavy

EXPERIMENTAL

Minidose group - will receive spinal anesthesia induced by Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml)

Drug: Bupivacaine and Fentanyl

Interventions

Bupivacaine and FentanylDRUG

Spinal anesthesia with Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml)

Also known as: Marcaine Spinal 0.5% Heavy, Fentanyl-Janssen
Minidose of Marcaine Spinal 0.5% Heavy
BupivacaineDRUG

Spinal anesthesia with Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml)

Also known as: Marcaine Spinal 0.5% Heavy
Standard dose Marcaine Spinal 0.5% Heavy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women over 38 weeks of pregnancy, who read and write Hebrew
  • ASA class I and II
  • Age between 18 and 40 years
  • Weight 50-100 kg
  • Elective Cesarean Section for singlet pregnancy

You may not qualify if:

  • Previous history of two or more Cesarean Sections
  • Contraindications for regional anesthesia
  • Active pain before surgery
  • Non singlet pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

Location

MeSH Terms

Interventions

BupivacaineFentanyl

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Boris Yanovsky, MD

    Bnai Zion Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Boris Yanovsky, MD

CONTACT

+972 50 626788boris.yanovsky@b-z.org.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 20, 2011

First Posted

February 25, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 25, 2011

Record last verified: 2011-01

Locations

IL(1)