Trial Outcomes & Findings for Study of Transverse Abdominis Plane (TAP) Block in Children Undergoing Hydrocelectomy and/or Hernia Repair Surgery (NCT NCT01698268)

Last Updated: 2017-08-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Admission into PACU

Results posted on

2017-08-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	TAP Group 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.	Local Infiltration Group 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.
Overall Study STARTED	25	25
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	TAP Group 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.	Local Infiltration Group 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.
Overall Study Physician Decision	2	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAP Group n=23 Participants 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.	Local Infiltration Group n=24 Participants 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 n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants

PRIMARY outcome

Timeframe: Admission into PACU

Outcome measures

Outcome measures
Measure	TAP Group n=23 Participants 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.	Local Infiltration Group n=24 Participants 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.
FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 3.5

Adverse Events

TAP Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Local Infiltration Group

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TAP Group n=23 participants at risk 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.	Local Infiltration Group n=24 participants at risk 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.
General disorders Agitation	4.3% 1/23 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Gastrointestinal disorders Diarrhea	8.7% 2/23 • Number of events 2 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	0.00% 0/24 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Gastrointestinal disorders Nausea	4.3% 1/23 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Gastrointestinal disorders Vomiting	4.3% 1/23 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Gastrointestinal disorders Abdominal swelling	4.3% 1/23 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	0.00% 0/24 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
General disorders Restlessness	0.00% 0/23 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Surgical and medical procedures Incisional pain	0.00% 0/23 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Skin and subcutaneous tissue disorders Skin irritation	4.3% 1/23 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Skin and subcutaneous tissue disorders skin inflammation	4.3% 1/23 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	0.00% 0/24 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Renal and urinary disorders Urinary urgency	0.00% 0/23 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 1/23 • Number of events 1 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.	0.00% 0/24 • Adverse Events were collected from the time of consent through the time of a followup phone call 24 hours post discharge from the hospital.

Additional Information

Kaveh Aslani, MD

Beaumont Health

Phone: 248-898-81905

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place