Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00564655
First received: November 27, 2007
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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
Anesthesia
Enteral Nutrition
Procedure: bupivacaine with epinephrine (mid and upper abdomen)
Procedure: bupivacaine with epinephrine (transversus abdominis plane)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Morphine consumption [ Time Frame: For 24 hours after the time of first eye-opening post-procedure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time until the patient is discharged from PACU to the ward [ Time Frame: At time of PACU discharge ] [ Designated as safety issue: No ]
  • Parent satisfaction with analgesia and the procedure [ Time Frame: On the day following surgery ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: October 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients in the control group will receive localized infiltration of local anesthesia at the beginning of the procedure as is current standard practice.
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.
Experimental: 2
Patients in the experimental group will receive a regional anesthetic blockade of the anterior abdominal wall via the transversus abdominis plane.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564655

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Conor Mc Donnell, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00564655     History of Changes
Other Study ID Numbers: 1000011192
Study First Received: November 27, 2007
Last Updated: July 23, 2013
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
Gastric Tube Insertion
Anesthesia
Regional Anesthetic
Transversus Abdominal Plane

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Sensory System Agents

ClinicalTrials.gov processed this record on October 19, 2014