Clinical trial NCT00564655: Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion
Official title: Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anesthesia
Enteral Nutrition
Keywords: pediatrics
Gastric Tube Insertion
Anesthesia
Regional Anesthetic
Transversus Abdominal Plane
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2007-11-28
Enrollment: 3
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Morphine consumption
timeFrame: For 24 hours after the time of first eye-opening post-procedure
measure: Pain, sedation, nausea & vomiting scores
timeFrame: 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:
measure: Time until the patient is discharged from PACU to the ward
timeFrame: At time of PACU discharge
measure: Parent satisfaction with analgesia and the procedure
timeFrame: On the day following surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Conor Mc Donnell, MD
role: PRINCIPAL_INVESTIGATOR
References: