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

Not Applicable

Completed

• Conditions: Hydrocele; Inguinal Hernia
• Interventions: Procedure: Local Infiltration; Procedure: TAP block

• Registration Number: NCT01698268
• Lead Sponsor: Kaveh Aslani, MD

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-02
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2017-01-18
• Results First Submitted QC: 2017-03-31
• Results First Posted: 2017-06-19
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Infiltration Group	Local Infiltration	Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
TAP Group	TAP block	Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.

Primary Outcome Measures

Name	Time	Method
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)	Admission into PACU	FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.

Trial Locations

Locations (1)

Beaumont Health System; 🇺🇸 Royal Oak, Michigan, United States