Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery

Inguinal Hernia Clinical Trial

— TAP  

Official title:

The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698268
• Other study ID #: 2011-213
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2012
• Last updated: June 2, 2015
• Start date: February 2012
• Est. completion date: November 2014

Study information

• Verified date: June 2015
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study measures the difference in pain after hernia &/or hydrocele repair based on site of local anesthesia injection.

Description:

This single-center, prospective, single blind, randomized study will enroll 50 subjects who are scheduled for elective hydrocelectomy and/or hernia repair. At Beaumont Health System, post-operative pain management in children is managed either via oral/parenteral opiates and opiate adjuncts, surgeon-administered field blocks (instillation of local anesthetics in the general area of incision), or via regional techniques (spinal, epidural, or peripheral nerve blocks). We have designed this study to determine if there is improved qualitative and quantitative post-operative pain control in patients receiving TAP block versus intraoperative peri-incisional, surgeon administered field block. Once informed consent has been given, each patient will be randomized (like flip of the coin) to either Transverse Abdominis Plane Block (TAP Block)or surgeon administered anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• Children 2-8 years of age

• Elective inguinal hernia repair, inguinal hernia repair with peritoneoscopy and/or hydrocelectomy to be performed in the Center for Children's Surgery, Beaumont Hospital, Royal Oak

• American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness, or mild systemic disease that is well controlled, eg. mild asthma)

Exclusion Criteria:

• History of allergy to study medications

• Enrollment in concurrent research study

• Pregnant patients*

• Students/trainees/staff*

• Mentally disabled/cognitively impaired*

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hydrocele
• Inguinal Hernia

Intervention

Procedure:
• TAP block
TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.
• Local Infiltration
Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.

Locations

Country	Name	City	State
United States	Beaumont Health System	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Kaveh Aslani, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs).		Admission into PACU until hospital discharge, between 1 - 2 hours.	No