NCT00808327

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2008

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

7 months

First QC Date

December 11, 2008

Last Update Submit

November 19, 2009

Conditions

Pain

Keywords

Cesarean sectionSpinal

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is the maximal degree of abdominal sensation felt by the patient during surgery.

    1 hour

Secondary Outcomes (10)

  • Speed of onset of block to T4 dermatome (minutes), as well as highest level of block (dermatomal level) and degree of motor block (Bromage scale)

    30 minutes

  • The degree of patient discomfort will be evaluated using a 10 cm linear visual analog scale (VAS).

    1 hour

  • The amount of additional IV analgesia administered during the intraoperative period.

    1 hour

  • Time to regression of block (minutes)

    4 hours

  • Duration of analgesia (hours)

    24 hours

  • +5 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Bupivacaine alone

Drug: Bupivacaine

2

ACTIVE COMPARATOR

Bupivacaine plus Fentanyl

Drug: Bupivacaine, fentanyl

Interventions

BupivacaineDRUG

A single, 15mg, intrathecal dose of bupivacaine.

Also known as: Marcaine
1
Bupivacaine, fentanylDRUG

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

Also known as: Marcaine
2

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

BupivacaineFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alison J Macarthur, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 15, 2008

Study Start

January 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations

CA(1)