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

NCT ID: NCT01698268

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-11-30

Brief Summary

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

Detailed 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.

Conditions

Hydrocele; Inguinal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TAP Group

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

Group Type: EXPERIMENTAL

TAP block

Intervention Type: PROCEDURE

TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.

Local Infiltration Group

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

Group Type: ACTIVE_COMPARATOR

Local Infiltration

Intervention Type: PROCEDURE

Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.

Interventions

TAP block

TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.

Intervention Type: PROCEDURE

Local Infiltration

Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.

Intervention Type: PROCEDURE

Eligibility Criteria

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*

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaveh Aslani, MD

OTHER

Sponsor Role: lead

Responsible Party

Kaveh Aslani, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kaveh Aslani, MD

Role: PRINCIPAL_INVESTIGATOR

Beaumont Health

Locations

Beaumont Health System

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2011-213

Identifier Type: -

Identifier Source: org_study_id