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Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rectus sheath block
local anesthetic infiltration
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain relief after umbilical hernia repair, morphine consumption, plasma bupivacaine levels

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children between 1 ≤ 17 years of age
  • ASA I (normal healthy children) and II (Children with mild systemic disease that has no functional effects)
  • Having elective umbilical hernia repair

Exclusion Criteria:

  • Children < 1 year of age or > 17 years of age
  • Family has no telephone for follow up phone call
  • Allergy or sensitivity to bupivacaine or morphine
  • Any coagulation abnormalities
  • Emergency surgery

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

rectus sheath block

local anesthetic infiltration

Outcomes

Primary Outcome Measures

pain scores

Secondary Outcome Measures

morphine consumption
plasma bupivacaine levels

Full Information

First Posted
February 3, 2009
Last Updated
June 10, 2014
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00836134
Brief Title
Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair
Official Title
Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the effectiveness of local infiltration to an ultrasound guided nerve block placed by the anesthesiologist for children undergoing umbilical hernia repair. This is a double-cohort, double blinded, randomized study comparing local infiltration to ultrasound-guided rectus sheath block in children 1 to 17 years of age undergoing epigastric or umbilical hernia repair. We will first compare pain scores to see if one method is more adequate then the other in providing post-op analgesia. Our second aim is to compare morphine consumption between the two groups. Our third aim is to measure the levels of local anesthetic in the blood following local anesthetic infiltration or USGRSB.
Detailed Description
Healthy children, aged 1 to 17 years of age, undergoing elective umbilical hernia repairs will be considered for this study. After informed consent/assent has been obtained, the subject will be randomized into one of two groups. Group A will receive local infiltration of 0.25% bupivacaine by the surgeon at the end of the subject's surgery. Group B will undergo an ultrasound-guided rectus sheath block using 0.25% bupivacaine prior to incision by an anesthesiologist skilled in the performance of this block. All subjects will receive a standardized anesthetic for their surgery. Subjects assigned to Group A (local infiltration) will receive 2mcg/kg of fentanyl prior to incision for intra-operative pain management. Subjects assigned to Group B will have their Rectus Sheath Block and no fentanyl will be given at this time. Fentanyl is a short-acting opioid analgesic. It's duration of action in the dose we will be using is approximately one hour which is close to the expected length of surgery. Therefore, it is not expected to influence the pain management after surgery. Pain scores will be assessed by a member of the research team. They will be blinded to which technique the subject has been randomized to. This person will not be involved in the direct care of the subject. These observations will be made using an age-appropriate scoring system (FLACC or FACES scale). Scoring will be done every 5 minutes when the subject is in the recovery room and every 30 minutes when they are in Phase II. This will be done until the subject is discharged from the hospital. Families will be followed by phone for 48 h post discharge, to collect data on medication use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain relief after umbilical hernia repair, morphine consumption, plasma bupivacaine levels

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
rectus sheath block
Arm Title
2
Arm Type
Active Comparator
Arm Description
local anesthetic infiltration
Intervention Type
Procedure
Intervention Name(s)
rectus sheath block
Other Intervention Name(s)
bupivacaine
Intervention Description
ultrasound-guided rectus sheath block using 0.2ml/kg 0.25% bupivacaine bilaterally prior to skin incision
Intervention Type
Procedure
Intervention Name(s)
local anesthetic infiltration
Other Intervention Name(s)
bupivacaine
Intervention Description
Wound infiltration using 0.4ml/kg 0.25% bupivacaine by the surgeon at the end of surgery
Primary Outcome Measure Information:
Title
pain scores
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
morphine consumption
Time Frame
4 hours
Title
plasma bupivacaine levels
Time Frame
0, 10, 20, 30, 45, 60 minutes after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children between 1 ≤ 17 years of age ASA I (normal healthy children) and II (Children with mild systemic disease that has no functional effects) Having elective umbilical hernia repair Exclusion Criteria: Children < 1 year of age or > 17 years of age Family has no telephone for follow up phone call Allergy or sensitivity to bupivacaine or morphine Any coagulation abnormalities Emergency surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean H Flack, MBChB FCA
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair

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