NCT00298571

Brief Summary

The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean deliveries will decrease post-op pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

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

February 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 15, 2012

Status Verified

February 1, 2006

First QC Date

February 28, 2006

Last Update Submit

June 14, 2012

Conditions

Pain, Postoperative

Keywords

Cesarean DeliveryPost-operativePainLocal Anesthetic

Outcome Measures

Primary Outcomes (2)

  • 1. Decreased post-op pain

  • 2. Decreased post-op narcotic use

Secondary Outcomes (1)

  • improved hospital stay satisfaction

Interventions

.5% bupivacaine with epinephrineDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant Women with scheduled cesarean delivery
  • able to perform informed consent

You may not qualify if:

  • Labor
  • chronic pain
  • allergic to local anesthetic
  • unable to perform informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

BupivacaineEpinephrine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Shelly Holmstrom, MD

    USF Department OB/Gyn

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2006

First Posted

March 2, 2006

Study Start

February 1, 2006

Study Completion

October 1, 2007

Last Updated

June 15, 2012

Record last verified: 2006-02

Locations

US(1)