Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies

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ClinicalTrials.gov Identifier: NCT01575028

Recruitment Status : Terminated (The study was allowed to expire due to changes in standard care for the patient population within the NCH institution.)

First Posted : April 10, 2012

Results First Posted : June 1, 2015

Last Update Posted : August 24, 2015

Sponsor:

Information provided by (Responsible Party):

Tarun Bhalla, MD, Nationwide Children's Hospital

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
Condition	Appendicitis
Interventions	Drug: Ropivacaine Drug: Bupivacaine
Enrollment	3

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Local Anesthetic Infiltration Injection	Transversus Abdominis Plane (TAP) Block
Arm/Group Description	Patients will receive local anesthe...	Patients will receive a transversus...
Arm/Group Description	Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery. Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon.	Patients will receive a transversus abdominis plane (TAP) block. Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
Period Title: Overall Study
Started	2	1
Completed	2	0
Not Completed	0	1
Reason Not Completed
Physician Decision	0	1

Baseline Characteristics

Arm/Group Title		Local Anesthetic Infiltration Injection	Transversus Abdominis Plane (TAP) Block	Total
Arm/Group Description		Patients will receive local anesthe...	Patients will receive a transversus...	Total of all reporting groups
Arm/Group Description		Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery. Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon.	Patients will receive a transversus abdominis plane (TAP) block. Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally	Total of all reporting groups
Overall Number of Baseline Participants		2	1	3
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2 participants	1 participants	3 participants
	<=18 years	2 100.0%	1 100.0%	3 100.0%
	Between 18 and 65 years	0 0.0%	0 0.0%	0 0.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	2 participants	1 participants	3 participants
		13.425 (4.871965722)	7.36 (0)	11.40 (4.91)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2 participants	1 participants	3 participants
	Female	0 0.0%	1 100.0%	1 33.3%
	Male	2 100.0%	0 0.0%	2 66.7%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2 participants	1 participants	3 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	2 100.0%	1 100.0%	3 100.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	2 participants	1 participants	3 participants
United States		2	1	3

Outcome Measures

1.Primary Outcome


Title	Post-operative Pain Relief
Description	Prospectively compare post-operative pain relief in pediatric patients...
Description	Prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia.
Time Frame	12 hours post-operatively

Outcome Measure Data

Analysis Population Description

Due to changes in surgical technique & protocols by the general surgeons, we were only able to recruit 3 study subjects and the study was terminated. No analysis was performed.


Arm/Group Title	Local Anesthetic Infiltration Injection	Transversus Abdominis Plane (TAP) Block
Arm/Group Description:	Patients will receive local anesthe...	Patients will receive a transversus...
Arm/Group Description:	Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery. Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon.	Patients will receive a transversus abdominis plane (TAP) block. Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Local Anesthetic Infiltration Injection	Transversus Abdominis Plane (TAP) Block
Arm/Group Description	Patients will receive local anesthe...	Patients will receive a transversus...
Arm/Group Description	Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery. Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon.	Patients will receive a transversus abdominis plane (TAP) block. Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
All-Cause Mortality
	Local Anesthetic Infiltration Injection	Transversus Abdominis Plane (TAP) Block
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Local Anesthetic Infiltration Injection	Transversus Abdominis Plane (TAP) Block
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/2 (0.00%)	0/1 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Local Anesthetic Infiltration Injection	Transversus Abdominis Plane (TAP) Block
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/2 (0.00%)	0/1 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Tarun Bhalla
Organization:	Nationwide Children's Hospital
Phone:	(614) 722-4200
EMail:	Tarun.Bhalla@NationwideChildrens.org

Publications:

McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. Erratum in: Anesth Analg. 2007 May;104(5):1108.

Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7.

Layout table for additonal information

Responsible Party:	Tarun Bhalla, MD, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:	NCT01575028
Other Study ID Numbers:	IRB12-00140
First Submitted:	April 5, 2012
First Posted:	April 10, 2012
Results First Submitted:	May 14, 2015
Results First Posted:	June 1, 2015
Last Update Posted:	August 24, 2015

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