MedDataX Logo

Spinal Anesthesia for Cesarean Delivery: Bupivacaine With or Without Fentanyl

NCT ID: NCT00808327

Last Updated: 2009-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The safest form of anesthesia for Cesarean section is a spinal anesthetic. All spinal anesthetics contain a local anesthetic and/or a narcotic. A drug named bupivacaine is the most commonly used local anesthetic in spinal anesthetics for Cesarean deliveries in North America. Another drug named fentanyl is the most commonly used narcotic. This study will look at whether a spinal anesthetic with 15mg of bupivacaine alone will be the same as a spinal anesthetic with 12mg of bupivacaine and 15ug of fentanyl.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There have been many studies looking at different doses and combinations of bupivacaine and fentanyl but there is no agreement among anesthesiologists as to the best combination of drugs.

The main problem with bupivacaine is that it causes hypotension (low blood pressure). When fentanyl is added to bupivacaine, a lower dose of bupivacaine can be used so that there is less of a fall in blood pressure. The main problem with fentanyl is itchiness and sleepiness. In the case of an emergency Cesarean section, the extra time needed to draw-up and administer a second medication may make a difference to the health of the baby.

Our goal is to determine whether high dose bupivacaine (15mg) alone will produce spinal anaesthesia for cesarean delivery equivalent to 12mg of intrathecal hyperbaric bupivacaine in combination with 15ug of intrathecal fentanyl.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cesarean section Spinal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Bupivacaine alone

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

A single, 15mg, intrathecal dose of bupivacaine.

2

Bupivacaine plus Fentanyl

Group Type ACTIVE_COMPARATOR

Bupivacaine, fentanyl

Intervention Type DRUG

A single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bupivacaine

A single, 15mg, intrathecal dose of bupivacaine.

Intervention Type DRUG

Bupivacaine, fentanyl

A single, 12 mg, intrathecal dose of bupivacaine, plus 15 micrograms of fentanyl

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Marcaine Marcaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy patients (ASA 1 or 2)
* BMI \< 40
* height between 5 \& 6 feet

Exclusion Criteria

* parturients with pregnancy induced hypertension or preeclampsia
* parturients with significant cardiac, renal or other organ-system disease which preclude choice of spinal anesthesia
* emergency delivery
* triplet or greater multiple gestation
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mount Sinai Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alison J Macarthur, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08-03

Identifier Type: -

Identifier Source: org_study_id