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

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?

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01559740
Enrollment
36
Registered
2012-03-21
Start date
2010-07-31
Completion date
Unknown
Last updated
2012-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

regional anesthesia, children, postoperative pain relief

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.

Interventions

DRUGBupivacaine

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.

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
TAP Block Concentration of Bupivacaine that Reduces Postoperative PainParticipants will be followed for the duration of anesthesia and after surgery, an average of 48 hoursThe 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

MeasureTime frameDescription
Dose of rescue medications given between the two groupsParticipants will be followed for the duration of anesthesia and after surgery, an average of 48 hoursThe 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 groupsParticipants will be followed for the duration of anesthesia and after surgery, an average of 48 hoursThe 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 groupsParticipants will be followed for the duration of anesthesia and after surgery, an average of 48 hoursThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026