NCT00578136

Brief Summary

Umbilical hernia repair is a common painful outpatient procedure performed in children. Often analgesia for this procedure is provided by using local infiltration of the surgical site by the surgeons and perioperative opioids and NSAIDS both IV and orally. The use of opioids can cause adverse side effects which include, but are not limited to nausea, vomiting, itching, and respiratory depression, etc. The rectus sheath block can be performed in these patients to decrease their post operative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 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

November 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 15, 2014

Completed
Last Updated

August 15, 2014

Status Verified

July 1, 2014

Enrollment Period

3.1 years

First QC Date

December 18, 2007

Results QC Date

December 7, 2012

Last Update Submit

July 30, 2014

Conditions

Umbilical Hernia

Keywords

Rectus SheathLocal infiltrationPain Control

Outcome Measures

Primary Outcomes (1)

  • The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia.

    total postoperative opioid and any additional analgesic medications.

    immediate to 24 hour post-operatively

Secondary Outcomes (1)

  • The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management.

    immediate to 24 hours post-operatively

Study Arms (2)

1

ACTIVE COMPARATOR

1\) One group will receive the rectus sheath block prior to Umbilical hernia repair.

Drug: Bupivacaine

2

ACTIVE COMPARATOR

2\) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.

Drug: Bupivacaine

Interventions

BupivacaineDRUG

Bupivacaine, 0.25%, dose amount is weight based, injection is divided per dise with rectus sheath injection or with local infiltration of the operative area.

12

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female subjects ages \> 5 to \< 18 years.
  • American Society of Anesthesiology (ASA)physical status 1 or 2.
  • Patients who undergo an umbilical hernia repair at CHOP.

You may not qualify if:

  • Parents/patients refusal to the placement of a rectus sheath nerve block.
  • Subjects with allergy to bupivacaine.
  • Patients who are developmentally delayed which precludes their participation in pain scale reporting.
  • Parents who do not comprehend English sufficiently well to read the consent and ask questions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hernia, UmbilicalAgnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Harshad Gurnaney, MBBS, MPH
Organization
The Children's Hospital of Philadelphia
gurnaney@email.chop.edu
267-426-5850

Study Officials

  • Harshad Gurnaney, MBBS

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 20, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2011

Last Updated

August 15, 2014

Results First Posted

August 15, 2014

Record last verified: 2014-07

Locations

US(1)