Transversus Abdominis Plane Blocks for Infants and Children for Postoperative Pain Control
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring regional anesthesia, children, postoperative pain relief
Eligibility 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
- Local infection of the abdominal wall.
- Allergy to amide local anesthetics
- History of significant cardiac disease or uncontrolled seizures.
- Allergy to rescue analgesia including acetaminophen and or hydromorphone.
- Neonates under 28 days.
- Inability for the family to complete the postoperative questionnaire
Sites / Locations
- Children's Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
0.25% Bupivacaine
0.125% Bupivacaine
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
TAP Block Concentration of Bupivacaine that Reduces Postoperative Pain
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
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
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
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.
Full Information
NCT ID
NCT01559740
First Posted
March 12, 2012
Last Updated
March 19, 2012
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT01559740
Brief Title
Transversus Abdominis Plane Blocks for Infants and Children for Postoperative Pain Control
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?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
regional anesthesia, children, postoperative pain relief
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.25% Bupivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
0.125% Bupivacaine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
TAP Block Concentration of Bupivacaine that Reduces Postoperative Pain
Description
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.
Time Frame
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Secondary Outcome Measure Information:
Title
Dose of rescue medications given between the two groups
Description
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.
Time Frame
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Title
Number of rescue medications given between the two groups
Description
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 Frame
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Title
Time the rescue medications were administered between the two groups
Description
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.
Time Frame
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Local infection of the abdominal wall.
Allergy to amide local anesthetics
History of significant cardiac disease or uncontrolled seizures.
Allergy to rescue analgesia including acetaminophen and or hydromorphone.
Neonates under 28 days.
Inability for the family to complete the postoperative questionnaire
Facility Information:
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19453587
Citation
Bielsky A, Efrat R, Suresh S. Postoperative analgesia in neonates after major abdominal surgery: 'TAP' our way to success! Paediatr Anaesth. 2009 May;19(5):541-2. doi: 10.1111/j.1460-9592.2009.02988.x. No abstract available.
Results Reference
background
PubMed Identifier
17179269
Citation
McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
Results Reference
background
PubMed Identifier
19335342
Citation
Suresh S, Chan VW. Ultrasound guided transversus abdominis plane block in infants, children and adolescents: a simple procedural guidance for their performance. Paediatr Anaesth. 2009 Apr;19(4):296-9. doi: 10.1111/j.1460-9592.2009.02958.x.
Results Reference
background
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Transversus Abdominis Plane Blocks for Infants and Children for Postoperative Pain Control
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