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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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Local Anesthetic Infiltration Injection Transversus Abdominis Plane (TAP) Block
Hide 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
Arm/Group Title Local Anesthetic Infiltration Injection Transversus Abdominis Plane (TAP) Block Total
Hide 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
Hide 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
2 1 3
1.Primary Outcome
Title Post-operative Pain Relief
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Local Anesthetic Infiltration Injection Transversus Abdominis Plane (TAP) Block
Hide 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   --/--   --/-- 
Hide 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%) 
Hide 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%) 
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
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