We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone (Ropivacaine)

This study has been terminated.
(Collected study data was not usable due to process miscommunications)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519584
First Posted: August 22, 2007
Last Update Posted: July 21, 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):
The Cleveland Clinic
Results First Submitted: April 18, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Pain
Interventions: Drug: Ropivacaine
Drug: dex
Drug: Bupivacaine
Drug: Saline

  Participant Flow
  Hide Participant Flow

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
Ropivacaine/Saline

Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block

Ropivacaine: 30 ml 0.5%

Saline: 0.9% saline; systemic and local

Ropivacaine/Dex

Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;

Ropivacaine: 30 ml 0.5%

dex: 8 mg (2 ml)

Bupivacaine/Dex

bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.

dex: 8 mg (2 ml)

Bupivacaine: 30 ml 0.5%

Bupivacaine/Saline

bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block

Bupivacaine: 30 ml 0.5%

Saline: 0.9% saline; systemic and local


Participant Flow:   Overall Study
    Ropivacaine/Saline   Ropivacaine/Dex   Bupivacaine/Dex   Bupivacaine/Saline
STARTED   54   54   54   56 
COMPLETED   54   54   54   56 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Ropivacaine/Saline

Ropivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block

Ropivacaine: 30 ml 0.5%

Saline: 0.9% saline; systemic and local

Ropivacaine/Dex

Ropivacaine and local steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic and 0.9% saline 2ml (systemic placebo) for intravenous injection with sedation for the block;

Ropivacaine: 30 ml 0.5%

dex: 8 mg (2 ml)

Bupivacaine/Dex

bupivacaine and systemic steroid: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block plus dexamethasone 8 mg (2 ml) administered intravenously with sedation administered for the block.

dex: 8 mg (2 ml)

Bupivacaine: 30 ml 0.5%

Bupivacaine/Saline

bupivacaine 30ml 0.5% ropivacaine plus 2 ml 0.9% saline (local placebo) for interscalene block and 0.9% saline 2 ml (systemic placebo) for intravenous injection with sedation for the block

Bupivacaine: 30 ml 0.5%

Saline: 0.9% saline; systemic and local

Total Total of all reporting groups

Baseline Measures
   Ropivacaine/Saline   Ropivacaine/Dex   Bupivacaine/Dex   Bupivacaine/Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 54   54   54   56   218 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 55 
 (44 to 55) 
 59 
 (49 to 68) 
 58 
 (53 to 64) 
 60 
 (51 to 68) 
 59 
 (50 to 60) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      21  38.9%      21  38.9%      21  38.9%      19  33.9%      82  37.6% 
Male      33  61.1%      33  61.1%      33  61.1%      37  66.1%      136  62.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   the Duration of Analgesia   [ Time Frame: surgical date to postoperative day 1 (pod 0 -1 day) ]

2.  Secondary:   Time to a Significant Increase in Shoulder Discomfort   [ Time Frame: during postoperative day 1 to 3 ]

3.  Secondary:   Maximum VRS Pain Scores at Rest   [ Time Frame: postoperative day 1 day 2, day 3. ]

4.  Secondary:   Total Opioid Consumption   [ Time Frame: during first 3 days after surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: K. C. Cummings III, MD
Organization: Cleveland Clinic
phone: 216-444-1016
e-mail: cummink2@ccf.org



Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00519584     History of Changes
Other Study ID Numbers: 07-459
First Submitted: August 21, 2007
First Posted: August 22, 2007
Results First Submitted: April 18, 2017
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017