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

NCT01559740 | Completed Phase 2 DMC

• 1 other identifier: CMH IRB 2009-13887
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

regional anesthesia; children; postoperative pain relief

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

Secondary Outcomes (3)

• Dose of rescue medications given between the two groups

  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

  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

  Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

Study Arms (2)

0.25% Bupivacaine

EXPERIMENTAL

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

0.125% Bupivacaine

EXPERIMENTAL

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

Interventions

Bupivacaine DRUG

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.

0.125% Bupivacaine; 0.25% Bupivacaine

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Children's Memorial Hospital

Chicago, Illinois, 60614, United States

Location

Related Publications (3)

• 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.

  PMID: 19453587 BACKGROUND

• 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.

  PMID: 17179269 BACKGROUND

• 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.

  PMID: 19335342 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 21, 2012
• Study Start: July 1, 2010
• Primary Completion: August 1, 2010
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

US (1)