Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair
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| First Received Date ICMJE | February 3, 2009 | ||||
| Last Updated Date | March 11, 2013 | ||||
| Start Date ICMJE | February 2009 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
pain scores [ Time Frame: 4 hours ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00836134 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair | ||||
| Official Title ICMJE | Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair | ||||
| 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. |
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| 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 ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Year to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00836134 | ||||
| Other Study ID Numbers ICMJE | RS_Rectus_sheath | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Sean Flack, Seattle Children's Hospital | ||||
| Study Sponsor ICMJE | Seattle Children's Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Seattle Children's Hospital | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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