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

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

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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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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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.
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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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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  Serious Adverse Events

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  Other Adverse Events

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  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
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  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: 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