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Bilateral Paravertebral Blockade (T7-10) vs. Incisional Local Anesthetic Administration for Pediatric Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380834
First Posted: June 27, 2011
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mihaela Visoiu, University of Pittsburgh
Results First Submitted: April 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pain, Postoperative
Interventions: Drug: control group
Drug: treatment group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Group

Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

Placebo Group

Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.

control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.


Participant Flow:   Overall Study
    Treatment Group   Placebo Group
STARTED   42   42 
COMPLETED   41   42 
NOT COMPLETED   1   0 
Physician Decision                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Group

Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

Placebo Group

Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.

control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.

Total Total of all reporting groups

Baseline Measures
   Treatment Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   42   84 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      42 100.0%      42 100.0%      84 100.0% 
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 
[Units: Years]
Median (Inter-Quartile Range)
 14.5 
 (12 to 16) 
 14 
 (12 to 15) 
 14 
 (12 to 16) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      32  76.2%      30  71.4%      62  73.8% 
Male      10  23.8%      12  28.6%      22  26.2% 
Region of Enrollment 
[Units: Participants]
     
United States   42   42   84 


  Outcome Measures
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1.  Primary:   Opioids Consumption Via PCA   [ Time Frame: 12 hrs after the blocks were done ]

Measure Type Primary
Measure Title Opioids Consumption Via PCA
Measure Description The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.
Time Frame 12 hrs after the blocks were done  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Group

Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

Placebo Group

Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.

control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.


Measured Values
   Treatment Group   Placebo Group 
Participants Analyzed 
[Units: Participants]
 41   42 
Opioids Consumption Via PCA 
[Units: Ng/kg/min]
Mean (Standard Deviation)
 107.29  (20.23)   100.17  (46.77) 

No statistical analysis provided for Opioids Consumption Via PCA



2.  Secondary:   Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).   [ Time Frame: 24 hrs after blocks were done or until the patient is discharged ]

Measure Type Secondary
Measure Title Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).
Measure Description The VAS (Visual Analog Scale, 0 mm “no pain”, to 100 mm,” the worst pain possible “) is used to assess postoperative pain for patients. Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after paravertebral block.
Time Frame 24 hrs after blocks were done or until the patient is discharged  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Group

Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

Placebo Group

Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.

control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.


Measured Values
   Treatment Group   Placebo Group 
Participants Analyzed 
[Units: Participants]
 41   42 
Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS). 
[Units: Units on a scale]
Mean (Standard Deviation)
   
4h VAS   42.68  (27.48)   38.95  (26.94) 
8h VAS   46.69  (30.15)   37.67  (27.88) 
12h VAS   43.88  (29.16)   36.07  (27.94) 
18h VAS   42.62  (31.22)   35.73  (27.59) 
24h VAS   42.17  (28.73)   29.98  (25.91) 

No statistical analysis provided for Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).



3.  Secondary:   Opioid Consumption   [ Time Frame: 24 hrs after blocks were done or until the patient is discharged ]

Measure Type Secondary
Measure Title Opioid Consumption
Measure Description Other secondary end points will total amount of fentanyl (mcg/kg), dilaudid (mcg/kg), oxycodone (mg/kg) and morphine (mg/kg) (after conversion of above opioids to morphine based on opioids potency) used at 24 hours postoperatively (or until the patient is discharged, if sooner).
Time Frame 24 hrs after blocks were done or until the patient is discharged  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Group

Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.

Placebo Group

Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.

control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.


Measured Values
   Treatment Group   Placebo Group 
Participants Analyzed 
[Units: Participants]
 41   42 
Opioid Consumption 
[Units: Mg/kg]
Mean (Standard Deviation)
 0.73  (0.32)   0.71  (0.26) 

No statistical analysis provided for Opioid Consumption




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.


Results Point of Contact:  
Name/Title: Dr. Mihaela Visoiu
Organization: Children's Hospital of UPMC
phone: 412-692-5260
e-mail: visoium@upmc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mihaela Visoiu, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01380834     History of Changes
Obsolete Identifiers: NCT01231048
Other Study ID Numbers: PRO10060554
First Submitted: June 22, 2011
First Posted: June 27, 2011
Results First Submitted: April 16, 2015
Results First Posted: May 21, 2015
Last Update Posted: November 20, 2017