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Trial record 17 of 328 for:    clonidine

Effectiveness of Perineural Clonidine as an Adjuvant With Ropivacaine for Popliteal Nerve Block in Patients Undergoing Foot and Ankle Surgery

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ClinicalTrials.gov Identifier: NCT01986751
Recruitment Status : Terminated (failure to enroll)
First Posted : November 18, 2013
Results First Posted : November 4, 2016
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Promil Kukreja, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Clonidine
Drug: ropivacaine
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clonidine and Ropivacaine Ropivacaine
Hide Arm/Group Description

A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).

Clonidine

ropivacaine

Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine

ropivacaine

Period Title: Overall Study
Started 10 4
Completed 0 2
Not Completed 10 2
Reason Not Completed
improperly consented             10             2
Arm/Group Title Clonidine and Ropivacaine Ropivacaine Total
Hide Arm/Group Description

A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).

Clonidine

ropivacaine

Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine

ropivacaine

Total of all reporting groups
Overall Number of Baseline Participants 10 4 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 4 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
4
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 4 participants 14 participants
Female
6
  60.0%
3
  75.0%
9
  64.3%
Male
4
  40.0%
1
  25.0%
5
  35.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 4 participants 14 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
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
10
 100.0%
4
 100.0%
14
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 4 participants 14 participants
10 4 14
1.Primary Outcome
Title Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group
Hide Description Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.
Time Frame baseline to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Study was prematurely terminated. No data were collected for this assessment.
Arm/Group Title Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Hide Arm/Group Description:
A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group
Hide Description Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.
Time Frame baseline to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Study was prematurely terminated. No data were collected for this assessment
Arm/Group Title Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Hide Arm/Group Description:
A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group
Hide Description The VAS score is measured as 0 - 10 with 0 being no pain to 10 being the worst pain imaginable to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.
Time Frame baseline to 24 hours post block
Hide Outcome Measure Data
Hide Analysis Population Description
Study was prematurely terminated. No data were collected for this assessment
Arm/Group Title Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Hide Arm/Group Description:
A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group
Hide Description Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group
Time Frame baseline to 24 hours post block
Hide Outcome Measure Data
Hide Analysis Population Description
Study was prematurely terminated. No data were collected for this assessment
Arm/Group Title Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Hide Arm/Group Description:
A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo
Hide Description Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure.
Time Frame baseline to discharge from hospital (expected 3 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Study was prematurely terminated. No data were collected for this assessment
Arm/Group Title Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Hide Arm/Group Description:
A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.
Hide Description Comparing the mean hours from start of procedure to discharge between the study group and the control group
Time Frame baseline to discharge (approximately 72 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Study was prematurely terminated. No data were collected for this assessment
Arm/Group Title Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Hide Arm/Group Description:
A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.
Hide Description Comparing the mean time to the first analgesic intake postoperative between the control group and the study group
Time Frame baseline to 24 hours post block
Hide Outcome Measure Data
Hide Analysis Population Description
Study was prematurely terminated. No data were collected for this assessment
Arm/Group Title Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Hide Arm/Group Description:
A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group
Hide Description Compare the mean VAS scores at 24 hours between the study group and the control group to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.
Time Frame baseline to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Study was prematurely terminated. No data were collected for this assessment
Arm/Group Title Clonidine and Ropivacaine Ropivacaine
Hide Arm/Group Description:
A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
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 Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Hide Arm/Group Description A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 20 ml of 0.5% ropivacaine
All-Cause Mortality
Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Clonidine and Ropivacaine (Study Group) Ropivacaine (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/4 (0.00%) 
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. Promil Kukreja
Organization: University of Alabama Birmingham
Phone: 205-996-7025
EMail: pkukreja@uabmc.edu
Layout table for additonal information
Responsible Party: Promil Kukreja, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01986751     History of Changes
Other Study ID Numbers: F130625002
First Submitted: October 31, 2013
First Posted: November 18, 2013
Results First Submitted: July 20, 2016
Results First Posted: November 4, 2016
Last Update Posted: November 4, 2016