Clinical trial NCT01559740: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: regional anesthesia
children
postoperative pain relief
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 36
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

  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

Primary outcomes:
measure: TAP Block Concentration of Bupivacaine that Reduces Postoperative Pain
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Secondary outcomes:
measure: Dose of rescue medications given between the two groups
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
measure: Number of rescue medications given between the two groups
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
measure: Time the rescue medications were administered between the two groups
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
Study officials:
References:
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.
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.
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.