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

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.
 
ClinicalTrials.gov Identifier: NCT01380834
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : May 21, 2015
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Mihaela Visoiu, University of Pittsburgh

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
Enrollment 84
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description

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.

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%.

Period Title: Overall Study
Started 42 42
Completed 41 42
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Arm/Group Title Treatment Group Placebo Group Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 42 42 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 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, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 42 participants 42 participants 84 participants
14.5
(12 to 16)
14
(12 to 15)
14
(12 to 16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 42 participants 84 participants
Female
32
  76.2%
30
  71.4%
62
  73.8%
Male
10
  23.8%
12
  28.6%
22
  26.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 42 participants 84 participants
42 42 84
1.Primary Outcome
Title Opioids Consumption Via PCA
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

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.

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%.

Overall Number of Participants Analyzed 41 42
Mean (Standard Deviation)
Unit of Measure: ng/kg/min
107.29  (20.23) 100.17  (46.77)
2.Secondary Outcome
Title Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

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.

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%.

Overall Number of Participants Analyzed 41 42
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
3.Secondary Outcome
Title Opioid Consumption
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description:

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.

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%.

Overall Number of Participants Analyzed 41 42
Mean (Standard Deviation)
Unit of Measure: mg/kg
0.73  (0.32) 0.71  (0.26)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Group Placebo Group
Hide Arm/Group Description

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.

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%.

All-Cause Mortality
Treatment Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Treatment Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/42 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   32/41 (78.05%)   32/42 (76.19%) 
Gastrointestinal disorders     
Nausea *  24/41 (58.54%)  20/42 (47.62%) 
Emesis *  14/41 (34.15%)  15/42 (35.71%) 
Injury, poisoning and procedural complications     
Back Pain *  3/41 (7.32%)  1/42 (2.38%) 
Vascular Puncture *  1/41 (2.44%)  4/42 (9.52%) 
Skin and subcutaneous tissue disorders     
Itching *  13/41 (31.71%)  8/42 (19.05%) 
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Mihaela Visoiu
Organization: Children's Hospital of UPMC
Phone: 412-692-5260
EMail: visoium@upmc.edu
Layout table for additonal information
Responsible Party: Mihaela Visoiu, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01380834    
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