NCT00450099

Brief Summary

Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the most commonly used drugs for that purpose. The efficacy of a certain medication injected epidurally depends on the dose that is given. A certain dose can be administered in different concentrations, which will consequently mean different volumes. Our hypothesis is that for each concentration of a certain drug, there has to be a minimum effective volume that will be associated with the best possible performance of the drug. This study is being conducted to find the minimum volume of bupivacaine (a local anesthetic) that produces successful analgesia in 95% of patients in labor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 17, 2007

Status Verified

December 1, 2007

First QC Date

March 19, 2007

Last Update Submit

December 12, 2007

Conditions

Acute Pain

Keywords

EpiduralLabor AnalgesiaBupivacaineDose-responseMinimum effective volume

Outcome Measures

Primary Outcomes (1)

  • Verbal Numeric Rating Scale (VNRS) less than or equal to 2 out of 10 during contraction

    20 minutes

Study Arms (1)

1

EXPERIMENTAL

Epidural, bupivacaine

Drug: bupivacaine

Interventions

bupivacaineDRUG

0.125% bupivacaine in a volume determined according to the biased coin up-down sequential allocation model, starting at 8mL.

1

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I or II
  • Full term (more than 37 weeks gestation)
  • Singleton pregnancy, vertex presentation
  • Regular painful contractions occurring at least every 5 minutes
  • Cervical dilatation \< 5 cm

You may not qualify if:

  • Any contraindication to epidural anesthesia
  • Accidental dural puncture
  • Allergy or hypersensitivity to bupivacaine
  • Women who have received opioids or sedative medications within the last 4 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jose CA Carvalho, MD PhD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 21, 2007

Study Start

October 1, 2005

Study Completion

August 1, 2007

Last Updated

December 17, 2007

Record last verified: 2007-12

Locations

CA(1)