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

July 23, 2013 updated by: The Hospital for Sick Children
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morphine consumption
Time Frame: For 24 hours after the time of first eye-opening post-procedure
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
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 Measures

Outcome Measure
Time Frame
Time until the patient is discharged from PACU to the ward
Time Frame: At time of PACU discharge
At time of PACU discharge
Parent satisfaction with analgesia and the procedure
Time Frame: On the day following surgery
On the day following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Conor Mc Donnell, MD, The Hospital for Sick Children, Toronto Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (ESTIMATE)

November 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000011192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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