NCT02879435

Brief Summary

This research will explore the question of whether preincisional skin infiltration with bupivacaine 0.25% decreases postoperative pain after Cesarean delivery.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

June 17, 2016

Last Update Submit

August 22, 2016

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • Final score on the visual analogous scale

    120 minutes after arrival in the recovery room

Secondary Outcomes (1)

  • Additional amount of analgesia provided patient as part of routine care

    Post 120 minutes after arrival in the recovery room

Study Arms (2)

bupivacaine

EXPERIMENTAL

Intervention

Drug: Bupivacaine

Placebo

PLACEBO COMPARATOR

Control

Other: Placebo

Interventions

BupivacaineDRUG

pre-operative wound infiltration with 10 ml of numbing medicine

Also known as: Marcaine
bupivacaine
PlaceboOTHER

pre-operative wound infiltration with 10 ml of sterile water

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adult pregnant women to age 45 with scheduled cesarean sections at Mercy Hospital and Medical Center

You may not qualify if:

  • Emergent cesarean sections and subjects with contraindications to bupivacaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mercy Hospital & Medical Center

Chicago, Illinois, 60616, United States

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Rohitkumar Vasa, MD

    IRB Chair

    STUDY CHAIR

Central Study Contacts

Kathy Tom, DO

CONTACT

4158286323kptom168@gmail.com

Mark Kosanovich, MD

CONTACT

3125672402mekosanovich@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 17, 2016

First Posted

August 25, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

August 25, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)