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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00836134
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : June 12, 2014
Information provided by (Responsible Party):
Sean Flack, Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Pain Procedure: rectus sheath block Procedure: local anesthetic infiltration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair
Study Start Date : February 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Ultrasound

Arm Intervention/treatment
Experimental: 1
rectus sheath block
Procedure: rectus sheath block
ultrasound-guided rectus sheath block using 0.2ml/kg 0.25% bupivacaine bilaterally prior to skin incision
Other Name: bupivacaine

Active Comparator: 2
local anesthetic infiltration
Procedure: local anesthetic infiltration
Wound infiltration using 0.4ml/kg 0.25% bupivacaine by the surgeon at the end of surgery
Other Name: bupivacaine

Primary Outcome Measures :
  1. pain scores [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. morphine consumption [ Time Frame: 4 hours ]
  2. plasma bupivacaine levels [ Time Frame: 0, 10, 20, 30, 45, 60 minutes after injection ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00836134

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United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
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Principal Investigator: Sean H Flack, MBChB FCA University of Washington
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Responsible Party: Sean Flack, Principal Investigator, Seattle Children's Hospital Identifier: NCT00836134    
Other Study ID Numbers: RS_Rectus_sheath
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: June 12, 2014
Last Verified: June 2014
Keywords provided by Sean Flack, Seattle Children's Hospital:
pain relief after umbilical hernia repair
morphine consumption
plasma bupivacaine levels
Additional relevant MeSH terms:
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Hernia, Umbilical
Pain, Postoperative
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents