Regional Anesthesia Block of the Transversus Abdominis Plane in Children Undergoing Gastric Tube Insertion
|Anesthesia Enteral Nutrition||Procedure: bupivacaine with epinephrine (mid and upper abdomen) Procedure: bupivacaine with epinephrine (transversus abdominis plane)||Phase 3|
|Study Design:||Allocation: Randomized
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|
- Morphine consumption [ Time Frame: 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 ]
- Time until the patient is discharged from PACU to the ward [ Time Frame: At time of PACU discharge ]
- Parent satisfaction with analgesia and the procedure [ Time Frame: On the day following surgery ]
|Study Start Date:||October 2007|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564655
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Conor Mc Donnell, MD||The Hospital for Sick Children, Toronto Canada|