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

March 19, 2012 updated by: Ann & Robert H Lurie Children's Hospital of Chicago

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?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
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
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.
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
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
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.
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ann & Robert H Lurie Children's Hospital of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMH IRB 2009-13887

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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