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Trial record 13 of 326 for:    clonidine

Ropivacaine With Clonidine For Pediatric Rectus Sheath Blocks- The Magic Combination

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ClinicalTrials.gov Identifier: NCT02439281
Recruitment Status : Terminated (The patients were discharged on the day of the surgery.)
First Posted : May 8, 2015
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
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 Postoperative Pain
Interventions Drug: Clonidine
Drug: Ropivacaine
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ropivacaine Group Ropivacaine/ Clonidine Group
Hide Arm/Group Description

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Period Title: Overall Study
Started 24 26
Completed 24 26
Not Completed 0 0
Arm/Group Title Ropivacaine Group Ropivacaine/ Clonidine Group Total
Hide Arm/Group Description

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Total of all reporting groups
Overall Number of Baseline Participants 24 26 50
Hide Baseline Analysis Population Description
1 patient withdrew the consent and one surgery was cancelled but these 2 patients were included in age , gender , weight and demographics. Blocks done on only 48 Only the patients that had the time when the numbness went away were compared
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
<=18 years
24
 100.0%
26
 100.0%
50
 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 24 participants 26 participants 50 participants
13.
(11.50 to 15.50)
13
(11 to 15)
13
(11 to 15.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 26 participants 50 participants
Female
13
  54.2%
12
  46.2%
25
  50.0%
Male
11
  45.8%
14
  53.8%
25
  50.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
preoperative anxiety   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 21 participants 24 participants 45 participants
33
(31 to 39)
39
(31.5 to 45)
35
(31 to 45)
[1]
Measure Description: To measure anxiety , the participants completed the state version of the State-Trait Anxiety Inventory for Children . This scale consists of 20 statements that ask the patient how they feel at that particular moment (e.g., “I feel…”), by checking one of the three alternatives that describe the child best (e.g., “very calm,” “calm,” or “not calm”). The total score for this scale ranges from 20-60. The highest number means more anxiety, worse outcome Only patients with completed scale were included
[2]
Measure Analysis Population Description: data was available only for the patients listed, 21, respectively 24 in each group
1.Primary Outcome
Title Duration of Sensory Block (Paresthesia)
Hide Description The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine result in longer duration of sensory block (paresthesia) compared to ropivacaine alone.
Time Frame Indicated by return of normal sensation (expected average of 12 hours after block placement).
Hide Outcome Measure Data
Hide Analysis Population Description
only patients that were able to report the time when the numbness went away were analysed and compared
Arm/Group Title Ropivacaine/ Clonidine Group Ropivacaine Group
Hide Arm/Group Description:

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Overall Number of Participants Analyzed 20 17
Median (Inter-Quartile Range)
Unit of Measure: minutes
823.5
(509.50 to 1080)
540
(360 to 1015)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine/ Clonidine Group, Ropivacaine Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4510
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Satisfaction With Pain Control From Patient
Hide Description The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in better satisfaction with pain control.
Time Frame Prior to hospital discharge (up to 24 hours after surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
only patients with satisfaction scores documented and other inclusion criteria met were analysed and compared; A numeric satisfaction scale 1-10 ( 1 not satisfied, 10 being very satisfied) was used
Arm/Group Title Ropivacaine/ Clonidine Group Ropivacaine Group
Hide Arm/Group Description:

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Overall Number of Participants Analyzed 20 16
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
9
(9 to 10)
9
(8 to 10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine/ Clonidine Group, Ropivacaine Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8914
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Complications Rate
Hide Description The investigators expect no difference in incidence of complications (e.g. oversedation, hypotension, bradycardia episodes, etc.).
Time Frame until study completion
Hide Outcome Measure Data
Hide Analysis Population Description
The patients that received a nerve block were analysed.
Arm/Group Title Ropivacaine/ Clonidine Group Ropivacaine Group
Hide Arm/Group Description:

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Overall Number of Participants Analyzed 25 24
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.0%
1
   4.2%
4.Secondary Outcome
Title Change in Anxiety Scores
Hide Description The investigators hypothesize that patient postoperative anxiety scores are lower in the Ropivacaine/Clonidine group and postoperative anxiety scores decrease more in Ropivacaine /Clonidine Group, than in Ropivacaine Group.
Time Frame 6 hours after block placement
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients that a completed anxiety scale were analyzed . State-Trait Anxiety Inventory for Children consists of 20 statements; how they feel at that particular moment ( “I feel…”), by checking one of the three alternatives that describe the child best “very calm,” “calm,” or “not calm”). The total score ranges from 20-60 ( worse outcome).
Arm/Group Title Ropivacaine Group Ropivacaine/ Clonidine Group
Hide Arm/Group Description:

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Overall Number of Participants Analyzed 18 23
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
30
(27 to 30)
29
(26 to 32)
5.Secondary Outcome
Title Duration of Analgesia at Umbilicus Instrument Site-How Many Minutes Passed From the Time When the Blocks Where Performed Until Patient Reported Pain at Umbilicus
Hide Description The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in longer duration of analgesia and decreased pain scores compared to ropivacaine alone.
Time Frame indicated by the first request for pain medication at umbilicus site
Hide Outcome Measure Data
Hide Analysis Population Description
only patients with documented duration of numbness and documented first pain scores at umbilicus were included in analysis of this secondary outcome
Arm/Group Title Ropivacaine/ Clonidine Group Ropivacaine Group
Hide Arm/Group Description:

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Overall Number of Participants Analyzed 16 15
Median (Inter-Quartile Range)
Unit of Measure: minutes
230
(137.50 to 388.00)
240
(144 to 359)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine/ Clonidine Group, Ropivacaine Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9531
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Average Pain Severity at the Umbilicus Laparoscopic Site
Hide Description Numeric Rating Pain Scores ( 0-10), will be obtained every 2 hours after PACU discharge up to 18 hours or until hospital discharge, whichever occurs first. The pain score of 0, means no pain, is a good outcome , and a pain score of 10 is excruciating pain, a very bad outcome. The average of these scores will be evaluated.The pain scores will not longer be documented after the numbness went away.
Time Frame Logistic regression of the 4 th pain score assessment
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with available average pain scores at the 4 th pain assessment were compared.
Arm/Group Title Ropivacaine Group Ropivacaine/ Clonidine Group
Hide Arm/Group Description:

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Overall Number of Participants Analyzed 19 18
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(0 to 2)
1.5
(0 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine Group, Ropivacaine/ Clonidine Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7780
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Medication Consumption
Hide Description Total intravenous morphine equivalents mg/kg
Time Frame 18 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with successful blocks were included. Two patients were deemed to have incomplete/ failed blocks and 2 patients did not have any blocks.
Arm/Group Title Ropivacaine/ Clonidine Group Ropivacaine Group
Hide Arm/Group Description:

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Overall Number of Participants Analyzed 25 21
Median (Inter-Quartile Range)
Unit of Measure: mg/kg
0.20
(0.17 to 0.24)
0.22
(0.15 to 0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine/ Clonidine Group, Ropivacaine Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5692
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame through study completion, an average 36 hours
Adverse Event Reporting Description Only patients that underwent the rectus sheath blocks were included in the adverse report description. Two patients were included in the study, but after randomization, 1 surgery was canceled, and another one was withdrew by the father. These 2 patients did not underwent any blocks
 
Arm/Group Title Ropivacaine/ Clonidine Group Ropivacaine Group
Hide Arm/Group Description

Ropivacaine/ Clonidine Group will receive ropivacaine 0.5% (10 ml) and clonidine (2mcg/kg) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Clonidine: Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilaterally in the posterior rectus sheath, at the umbilicus location.

Ropivacaine: One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block

All-Cause Mortality
Ropivacaine/ Clonidine Group Ropivacaine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ropivacaine/ Clonidine Group Ropivacaine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ropivacaine/ Clonidine Group Ropivacaine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/23 (0.00%) 
I had to stop the study after 50 patients because the patients that underwent laparoscopic appendectomy were sent home on a day of surgery, before the numbness wore off.
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: Mihaela Visoiu
Organization: U Pittsbutgh, UPMC Children's Hospital
Phone: 4126925260
EMail: visoium@upmc.edu
Publications:
Spielberger Charles Donald ECD. State-trait Anxiety Inventory for Children: STAIC : How I Feel Questionnaire : Professional Manual 1973.
Layout table for additonal information
Responsible Party: Mihaela Visoiu, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02439281     History of Changes
Other Study ID Numbers: PRO14100075
First Submitted: April 16, 2015
First Posted: May 8, 2015
Results First Submitted: April 30, 2019
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019