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

NCT00564655 | Terminated Phase 3

• 1 other identifier: 1000011192
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Enteral Nutrition

Keywords

pediatrics; Gastric Tube Insertion; Anesthesia; Regional Anesthetic; Transversus Abdominal Plane

Outcome Measures

Primary Outcomes (2)

• Morphine consumption

  For 24 hours after the time of first eye-opening post-procedure

• Pain, sedation, nausea & vomiting scores

  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 Outcomes (2)

• Time until the patient is discharged from PACU to the ward

  At time of PACU discharge

• Parent satisfaction with analgesia and the procedure

  On the day following surgery

Study Arms (2)

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.

Procedure: bupivacaine with epinephrine (mid and upper abdomen)

2

EXPERIMENTAL

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)

Interventions

bupivacaine with epinephrine (mid and upper abdomen) PROCEDURE

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.

1

bupivacaine with epinephrine (transversus abdominis plane) PROCEDURE

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.

2

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I - III
• One to ten years of age
• Scheduled to undergo gastric tube insertion in IGT
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Interventions

Bupivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Conor Mc Donnell, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 28, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: July 24, 2013

Record last verified: 2013-07

Locations

CA (1)