Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery (TAP)
|ClinicalTrials.gov Identifier: NCT01698268|
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : June 19, 2017
Last Update Posted : August 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hydrocele Inguinal Hernia||Procedure: TAP block Procedure: Local Infiltration||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: TAP Group
Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine.
Procedure: TAP block
TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.
Active Comparator: Local Infiltration Group
Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine.
Procedure: Local Infiltration
Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
- FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698268
|United States, Michigan|
|Beaumont Health System|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kaveh Aslani, MD||Beaumont Health System|