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

NCT01698268 | Completed Results DMC

• 1 other identifier: 2011-213
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hydrocele; Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

• FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)

  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.

  Admission into PACU

Study Arms (2)

TAP Group

EXPERIMENTAL

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

Procedure: TAP block

Local Infiltration Group

ACTIVE COMPARATOR

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

Procedure: Local Infiltration

Interventions

TAP block PROCEDURE

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

TAP Group

Local Infiltration PROCEDURE

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

Local Infiltration Group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• History of allergy to study medications
• Enrollment in concurrent research study
• Pregnant patients\*
• Students/trainees/staff\*
• Mentally disabled/cognitively impaired\*

Sponsors & Collaborators

• Kaveh Aslani, MD: lead

Study Sites (1)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Testicular Hydrocele; Hernia, Inguinal

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Limitations and Caveats

Of the 47 treated patients, the local infiltration was administered by 8 different surgeons while the TAP block was administered by 2 different anesthesiologists.

Results Point of Contact

• Title: Kaveh Aslani, MD
• Organization: Beaumont Health

kaslani@beaumont.org

248-898-81905

Study Officials

• Kaveh Aslani, MD

  Beaumont Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: October 2, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 24, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)