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Sponsored by: |
The Hospital for Sick Children |
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Information provided by: | The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT00564655 |
The objective of this trial is to examine if regional anesthetic blockade of the anterior abdominal wall via the transversus abdominis plane is a safe and feasible method of providing analgesia for children undergoing gastric tube insertion.
Condition | Intervention | Phase |
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Anesthesia Enteral Nutrition |
Procedure: bupivacaine with epinephrine (mid and upper abdomen) Procedure: bupivacaine with epinephrine (transversus abdominis plane) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion |
Estimated Enrollment: | 20 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Patients in the control group will receive localized infiltration of local anesthesia at the beginning of the procedure as is current standard practice.
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Procedure: bupivacaine with epinephrine (mid and upper abdomen)
Patients will receive localized infiltration of local anesthesia (0.25% bupivacaine with epinephrine 1:200,000) at the beginning of the procedure as is current standard practice. Localized anaesthetic of the mid and upper abdomen.
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2: Experimental
Patients in the experimental group will receive a regional anesthetic blockade of the anterior abdominal wall via the transversus abdominis plane.
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Procedure: bupivacaine with epinephrine (transversus abdominis plane)
0.6 cc/kg (to a maximum of 20 ccs) of 0.25% bupivacaine with epinephrine 1:200,000 will be injected into the neuro-vascular plane between the internal oblique and transversus abdominis muscles. Regional anaesthetic block of the transversus abdominis plane.
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Regional abdominal field blockade has been demonstrated to deliver effective analgesia for procedures involving the anterior abdominal wall and may represent a feasible, minimally invasive alternative to central neuraxial blockade for some procedures and surgery of the abdomen.
Regional anesthesia and analgesia techniques are commonly advocated for post-operative pain control in pediatric surgical practice. Regional techniques decrease morphine requirements and improve the quality of post-operative pain control and patient-parent satisfaction. The most commonly used technique is caudal anesthesia, which is generally indicated for urologic surgery, inguinal hernia repair and lower extremity surgery. Complications are rare and usually minor, however, the caudal technique is limited in its ability to provide reliable analgesia to the abdominal wall and for surgical procedures involving the mid and upper abdomen. A reasonable alternative for these surgical procedures is to perform a formal lumbar epidural. This provides excellent post-operative analgesia and complications are rare. However, when complications do occur they are not minor. Because of the risks and potential complications of epidural catheter insertion, current clinical experience reveals an unwillingness for parents to consent to this technique.
On average, two hundred gastric tube insertions are performed in Image Guided Therapy (IGT) per annum (year) in this institution. Current standard practice for post-procedure pain control is local infiltration of the insertion site with local anesthetic during the procedure and intravenous morphine supplemented by rectal acetaminophen post-operatively. A retrospective review of this patient group demonstrates that approximately 80% of patients require one to three doses of morphine in the first 12 - 16 hours after the procedure. Even a single dose of intravenous morphine can increase the incidence of vomiting in children undergoing day surgical procedures.
Ages Eligible for Study: | 1 Year to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Conor Mc Donnell, MD | 416-813-7654 ext 2687 | conor.mcdonnell@sickkids.ca |
Canada, Ontario | |
The Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Conor Mc Donnell, MD 416-813-7654 ext 2687 conor.mcdonnell@sickkids.ca | |
Principal Investigator: Conor Mc Donnell, MD | |
Sub-Investigator: John Justin, MD | |
Sub-Investigator: Mike Temple, MD | |
Sub-Investigator: Bairbre Connoly, MD | |
Sub-Investigator: Nicole Brown, BSc |
Principal Investigator: | Conor Mc Donnell, MD | The Hospital for Sick Children, Toronto Canada |
Responsible Party: | The Hospital for Sick Children ( Conor Mc Donnell/Principal Investigator ) |
Study ID Numbers: | 1000011192 |
Study First Received: | November 27, 2007 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00564655 |
Health Authority: | Canada: Health Canada |
pediatrics Gastric Tube Insertion Anesthesia Regional Anesthetic Transversus Abdominal Plane |
Bupivacaine Epinephrine |
Respiratory System Agents Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic beta-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Physiological Effects of Drugs Central Nervous System Depressants Anesthetics Anti-Asthmatic Agents Cardiovascular Agents |
Anesthetics, Local Pharmacologic Actions Adrenergic Agonists Mydriatics Sensory System Agents Autonomic Agents Therapeutic Uses Vasoconstrictor Agents Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |