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Transversus Abdominis Plane Blocks for Infants and Children for Postoperative Pain Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01559740
First received: March 12, 2012
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

After undergoing hernia surgery, hydrocelectomy or lower abdominal surgery, a child may experience some amount of pain in the post-operative period. As part of the anesthesia technique, the investigators routinely provide a nerve block done on the abdominal wall that will provide pain relief for at least 10 hours postoperatively. This is referred to as a TAP block. The purpose of this study is to determine if the nerve block performed with local anesthetic solution using a regular concentration solution vs. a diluted solution may offer different durations of pain relief.


Condition Intervention Phase
Postoperative Pain
 Drug: Bupivacaine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Transversus Abdominis Plane Blocks for Infants and Children for Postoperative Pain Control: Is it the Concentration or Volume of Local Anesthetic Solution That Improves Analgesia?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • TAP Block Concentration of Bupivacaine that Reduces Postoperative Pain [ Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours ] [ Designated as safety issue: No ]
    The difference in concentrations will be measured by using FLACC score every 5 mins for one hour after surgery in the Post Anesthesia Care Unit. Blood pressuer and heart rate will also be recorded.


Secondary Outcome Measures:
  • Dose of rescue medications given between the two groups [ Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours ] [ Designated as safety issue: No ]
    The dose of pain medications administered will be recorded by the nurse or study coordinator while in the hospital. The caregiver will record the dose of pain medications administered in a caregiver questionnaire sheet.

  • Number of rescue medications given between the two groups [ Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours ] [ Designated as safety issue: No ]
    The number of pain medications administered will be recorded by the nurse or study coordinator while in the hospital. The caregiver will record the number of pain medications administered in a caregiver questionnaire sheet.

  • Time the rescue medications were administered between the two groups [ Time Frame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours ] [ Designated as safety issue: No ]
    The time pain medications administered will be recorded by the nurse or study coordinator while in the hospital. The caregiver will record the time pain medications administered in a caregiver questionnaire sheet.


Enrollment: 36
Study Start Date: July 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.25% Bupivacaine
All children will receive a single dose of 1 mcg/kg of Fentanyl intravenously prior to incision. Group TAP 1 receiving a TAP block with 0.25% bupivacaine with 1:200,000 epinephrine at a dose of 1 mL/kg.
 Drug: Bupivacaine
This is being used as the local anesthetic for the TAP blocks at either 0.25% or 0.125%. The block will be done once during the procedure.
Experimental: 0.125% Bupivacaine
All children will receive a single dose of 1 mcg/kg of Fentanyl intravenously prior to incision. Group TAP 2 will receive a TAP block with a total dose of 1 mL/kg given at a concentration of 0.125% bupivacaine with 1:200,000 epinephrine.
 Drug: Bupivacaine
This is being used as the local anesthetic for the TAP blocks at either 0.25% or 0.125%. The block will be done once during the procedure.

Detailed Description:

Children undergoing groin surgery or abdominal surgery under general anesthesia are offered pain relief postoperatively using regional anesthesia techniques including a central block like a caudal block, or peripheral nerve blocks including ultrasound guided ilioinguinal nerve block or transversus abdominis plane (TAP) block. The TAP block, a peripheral block of the thoraco-lumbar nerve roots as they exit between the internal oblique and the transversus abdominis muscle can be easily visualized using ultrasound guidance. The TAP block has been used for analgesia following major surgeries including lower abdominal surgeries and in newborn infants following major abdominal procedures including colostomy placement.1 The purpose of this study is to determine if two different concentrations of bupivacaine delivered at a total dose of 1 mL/kg offer similar or altered analgesia, i.e., does the concentration of the anesthetic matter more than the volume of local anesthetic while performing a TAP block in children undergoing groin surgery. Parents and the investigators will be blinded to the solution used for the TAP block. The solution will be drawn up by an investigator who is not a participant in the patient's care in a sterile fashion.

  Eligibility

Ages Eligible for Study:   up to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children under 8 years of age presenting for hernia repair, hydrocelectomy or lower abdominal surgery
  • Estimated operative time approximately 3 hours
  • American Society of Anesthesiologists Classification ASA I or II
  • Parental consent to be included in the study

Exclusion Criteria:

  • Any contraindications to local anesthesia but not limited to

    1. Local infection of the abdominal wall.
    2. Allergy to amide local anesthetics
    3. History of significant cardiac disease or uncontrolled seizures.
    4. Allergy to rescue analgesia including acetaminophen and or hydromorphone.
    5. Neonates under 28 days.
  • Inability for the family to complete the postoperative questionnaire
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559740

Locations
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Publications:

Responsible Party: Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01559740     History of Changes
Other Study ID Numbers: CMH IRB 2009-13887
Study First Received: March 12, 2012
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
regional anesthesia
children
postoperative pain relief

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Bupivacaine
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013