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

Kaveh Aslani, MD

Status: Completed

Conditions: Hydrocele; Inguinal Hernia

Treatments: Procedure: Local Infiltration; Procedure: TAP block

Study type: Interventional

Funder types: Other

Identifiers

NCT01698268

2011-213

Details and patient eligibility

About

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

Full description

This single-center, prospective, single blind, randomized study will enroll up to 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.

Enrollment: 50 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

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*

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

TAP Group

Experimental group

Description:

Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.

Treatment:

Procedure: TAP block

Local Infiltration Group

Active Comparator group

Description:

Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.

Treatment:

Procedure: Local Infiltration