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

• Sponsor: Kaveh Aslani, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01698268
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hydrocele; Inguinal Hernia	Procedure: TAP block; Procedure: Local Infiltration	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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*

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beaumont Health System	Royal Oak	Michigan	United States	48073

Sponsors and Collaborators

• Kaveh Aslani, MD

Investigators

• Principal Investigator: Kaveh Aslani, MD, Beaumont Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kaveh Aslani, MD, Principal Investigator, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT01698268
• Other Study ID Numbers: 2011-213
• First Posted: Oct 2, 2012
• Last Update Posted: Aug 24, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hernia; Hernia, Inguinal

Study Results

Participant Flow

Recruitment Details	This single-center, prospective, single blind, randomized study enrolled subjects who were scheduled for elective hydrocelectomy and/or hernia repair at Beaumont Hospital-Royal Oak. The first procedure was on 3/16/2012 and the last one was on 11/12/2014.

Arm/Group Title	TAP Group	Local Infiltration Group
Arm/Group Description	Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.	Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
Period Title: Overall Study
STARTED	25	25
COMPLETED	23	24
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	TAP Group	Local Infiltration Group	Total
Arm/Group Description	Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.	Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.	Total of all reporting groups
Overall Participants	23	24	47
Age (Count of Participants)
<=18 years	23 100%	24 100%	47 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	3 13%	3 12.5%	6 12.8%
Male	20 87%	21 87.5%	41 87.2%
Region of Enrollment (Count of Participants)
United States	23 100%	24 100%	47 100%

Outcome Measures

1. Primary Outcome

Title	FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)
Description	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.
Time Frame	Admission into PACU

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TAP Group	Local Infiltration Group
Arm/Group Description	Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.	Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
Measure Participants	23	24
Median (Inter-Quartile Range) [units on a scale]	0	0

Adverse Events

Time Frame	Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Arm/Group Title	TAP Group		Local Infiltration Group
Arm/Group Description	Enrolled subjects will receive a TAP block with 0.5cc/kg of 0.25% ropivacaine. TAP block: TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.		Enrolled subjects will receive will receive local infiltration of 0.5 cc/kg of 0.25% ropivacaine. Local Infiltration: Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
All Cause Mortality
	TAP Group		Local Infiltration Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)
Serious Adverse Events
	TAP Group		Local Infiltration Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	TAP Group		Local Infiltration Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/23 (39.1%)		7/24 (29.2%)
Gastrointestinal disorders
Diarrhea	2/23 (8.7%)	2	0/24 (0%)	0
Nausea	1/23 (4.3%)	1	1/24 (4.2%)	1
Vomiting	1/23 (4.3%)	1	1/24 (4.2%)	1
Abdominal swelling	1/23 (4.3%)	1	0/24 (0%)	0
General disorders
Agitation	1/23 (4.3%)	1	1/24 (4.2%)	1
Restlessness	0/23 (0%)	0	1/24 (4.2%)	1
Renal and urinary disorders
Urinary urgency	0/23 (0%)	0	1/24 (4.2%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/23 (4.3%)	1	0/24 (0%)	0
Skin and subcutaneous tissue disorders
Skin irritation	1/23 (4.3%)	1	1/24 (4.2%)	1
skin inflammation	1/23 (4.3%)	1	0/24 (0%)	0
Surgical and medical procedures
Incisional pain	0/23 (0%)	0	1/24 (4.2%)	1

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.