|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00564655 |
|
Date of registration:
|
27/11/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion
|
|
Scientific title:
|
Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion |
|
Date of first enrolment:
|
October 2007 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00564655 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Conor Mc Donnell, MD |
|
Address:
|
|
|
Telephone:
|
416-813-7654 |
|
Email:
|
conor.mcdonnell@sickkids.ca |
|
Affiliation:
|
|
|
|
Name:
|
Conor Mc Donnell, MD |
|
Address:
|
|
|
Telephone:
|
416-813-7654 |
|
Email:
|
conor.mcdonnell@sickkids.ca |
|
Affiliation:
|
|
|
|
Name:
|
Conor Mc Donnell, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Hospital for Sick Children, Toronto Canada |
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- ASA I - III
- One to ten years of age
- Scheduled to undergo gastric tube insertion in IGT
- Signed informed consent
Exclusion Criteria:
- Patients requiring emergency procedures
- Refusal of regional block
- History of seizure disorder
- Allergy or sensitivity to bupivacaine, morphine, or radiological contrast
- Hepatic disease
- Bleeding disorder
- Use of pre-operative sedation
- Skin lesions or wounds at site of proposed needle insertion
- Evidence of peritonitis or septicemia
- Patients with ventriculo-peritoneal shunts in situ
- Patients taking any of the following drugs: procainamide, disopyramide, flecainide,
mexiletine, cimetidine and ranitidine
Age minimum:
1 Year
Age maximum:
10 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Anesthesia
|
|
Enteral Nutrition
|
|
Intervention(s)
|
|
Procedure: bupivacaine with epinephrine (mid and upper abdomen)
|
|
Procedure: bupivacaine with epinephrine (transversus abdominis plane)
|
|
Primary Outcome(s)
|
|
Morphine consumption
[Time Frame: For 24 hours after the time of first eye-opening post-procedure]
|
|
Pain, sedation, nausea & vomiting scores
[Time Frame: Pre-procedure; every 15 minutes from time of first eye-opening post-procedure until discharge from post-anesthesia care unit (PACU); on the ward at 2, 4, 8, 12, 16, and 24 hours]
|
|
Secondary Outcome(s)
|
|
Parent satisfaction with analgesia and the procedure
[Time Frame: On the day following surgery]
|
|
Time until the patient is discharged from PACU to the ward
[Time Frame: At time of PACU discharge]
|
|
Secondary ID(s)
|
|
1000011192
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|