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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
  Purpose
This study will test the hypothesis that ropivacaine in combination with either systemic or local steroid provides comparably longer-lasting analgesia tha ropivacaine alone.

Condition Intervention
Pain Drug: Ropivacaine Drug: dex Drug: Bupivacaine Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Duration of Interscalene Nerve Blocks With Ropivacaine Alone, Ropivacaine Mixed With Dexamethasone, and Ropivacaine Alone Combined With Systemic Dexamethasone

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • the Duration of Analgesia [ Time Frame: surgical date to postoperative day 1 (pod 0 -1 day) ]
    the interval between the onset of sensory block and the initial PACU use of opioid analgesia for surgical site pain


Secondary Outcome Measures:
  • Time to a Significant Increase in Shoulder Discomfort [ Time Frame: during postoperative day 1 to 3 ]
    the length of time until the patients' first report of surgical site pain.

  • Maximum VRS Pain Scores at Rest [ Time Frame: postoperative day 1 day 2, day 3. ]
    Verbal rating scales (VRS): a list of adjectives describing different levels of pain intensity with 0 = no pian and 10 = extremely intense pain. An adequate VRS of pain intensity should include adjectives that reflect the extremes of this dimension; from 'no pain' to 'extremely intense pain'. Patients are asked to read over the list of adjectives and select the word or phrase that best describes their level of pain on the scale from 0 to 10.

  • Total Opioid Consumption [ Time Frame: during first 3 days after surgery ]
    cumulative opioid consumption in oral oxycodone equivalents (mg) during the first 3 days after surgery.


Enrollment: 218
Study Start Date: July 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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
Drug: Ropivacaine
30 ml 0.5%
Drug: Saline
0.9% saline; systemic and local
Other Name: placebo
Active Comparator: 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;
Drug: Ropivacaine
30 ml 0.5%
Drug: dex
8 mg (2 ml)
Other Name: Ropivacaine/dex
Active Comparator: 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.
Drug: dex
8 mg (2 ml)
Other Name: Ropivacaine/dex
Drug: Bupivacaine
30 ml 0.5%
Placebo Comparator: 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
Drug: Bupivacaine
30 ml 0.5%
Drug: Saline
0.9% saline; systemic and local
Other Name: placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing open shoulder procedures such as rotator cuff repair, capsular shift, subacromial decompression
  • Age between 18 and 70 years

Exclusion Criteria:

  • Contradictions for interscalene block
  • Coagulopathy
  • Infection at the needle insertion site
  • Moderate to severe chronic obstructive pulmonary disease (COPD)
  • Contralateral pneumothorax of diaphragmatic paralysis
  • Pregnancy
  • Preexisting neuropathy involving the surgical limb
  • Systemic glucocorticoid treatment within the last six months of surgery
  • Routine opioid use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519584


Locations
United States, Ohio
Cleveland Clinic Hillcrest
Cleveland, Ohio, United States, 44112
Cleveland Clinic /Euclid Hospital
Euclid, Ohio, United States, 44119
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Kenneth Cummings III, M.D. Cleveland Clinic/Hillcrest
Study Director: Daniel I Sessler, MD The Cleveland Clinic
  More Information

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
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
Interscalene nerve block
Dexamethasone
Ropivacaine

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Bupivacaine
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents