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A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block

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. Identifier: NCT02151487
Recruitment Status : Completed
First Posted : May 30, 2014
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Information provided by (Responsible Party):
Dawood Nasir, University of Texas Southwestern Medical Center

Brief Summary:
The aim of this randomized, observer-blinded study is to evaluate the postoperative analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in supraclavicular nerve block. The investigators hypothesized that addition of dexamethasone and clonidine to ropivacaine would prolong the duration of analgesia in supraclavicular nerve block compared with ropivacaine alone.

Condition or disease Intervention/treatment
Upper Extremity Surgery Drug: Ropivacaine Drug: Ropivacaine and dexamethasone Drug: Ropivacaine and clonidine Drug: Ropivacaine, dexamethasone and clonidine

Detailed Description:

Subjects undergoing orthopedic surgery of upper extremities were randomized to be one of the three groups to receive supraclavicular nerve block with group 1: ropivacaine alone; group 2: ropivacaine and dexamethasone; group 3: ropivacaine and clonidine or group 4: ropivacaine and dexamethasone and clonidine combination.

Subjects were identified at the day surgery unit at Parkland hospital before the procedure and approached by their physician, the primary investigator, or research personnel for the consent for the study. If the subjects chooses and consents fully to participate, he or she was randomly assigned to receive one of the previously described local anesthetics for supraclavicular nerve block.

The following clinical outcomes were assessed for up to 24 hr: Duration of the block, onset of the block, postoperative pain scores, nausea, vomiting, and complications of peripheral nerve block. Pain was evaluated by using a linear 10-cm visual analog scale (VAS; 0=no pain, 10= worst imaginable pain) immediately before the block, 5, 10, 15 minutes and postoperatively on the arrival of Post Anesthesia Care Unit (PACU) within 15 minutes, discharge from the Day surgery Unit, and 24 hr. later at home via phone call visit.

Sensory and motor block in the related nerve dermatomes were assessed. Patient was instructed to document at what time did hand motion (finger movement) return and what time normal sensation return. Specific time for both events was sked to patient at phone call visit 24 hr later. Overall patient satisfaction was evaluated at the discharge from the day surgery and 24 hr after the block via phone visit.

At any point in which the patient is not experiencing pain relief after having received the injection, they were removed from the study and other anesthetic techniques will be applied to resolve their pain along with pharmacological management of their pain. Rescue antiemetic, which is standard of care, will be given to any patient who complains of nausea or vomiting.

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Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Comparison of Ropivacaine Alone Versus Ropivacaine With Dexamethasone or Clonidine Versus a Combination of Ropivacaine, Dexamethasone, and Clonidine for Supraclavicular Brachial Plexus Block Using Ultrasound:A Prospective, Observer-blinded, Randomized Study
Actual Study Start Date : March 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : August 20, 2016

Group/Cohort Intervention/treatment
Ropivacaine 0.5% 25 ml alone for supraclavicular block
Drug: Ropivacaine
Ropivacaine alone
Other Name: Noropin

Ropivacaine and dexamethasone
25 ml 0.5% ropivacaine + 4 mg dexamethasone
Drug: Ropivacaine and dexamethasone
Ropivacaine combination with dexamethasone
Other Name: Noropin and adjuvant

Ropivacaine and clonidine
25 ml 0.5% ropivacaine + 100 mcg clonidine
Drug: Ropivacaine and clonidine
Ropivacaine combination with clonidine
Other Name: Noropin and adjuvants

Ropivacaine, dexamethasone and clonidine
25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine
Drug: Ropivacaine, dexamethasone and clonidine
Ropivacaine combination with dexamethasone and clonidine
Other Name: Noropin and adjuvants

Primary Outcome Measures :
  1. Duration of the Sensorial Supraclavicular Block [ Time Frame: within 24-hr after surgery ]
    Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home

Secondary Outcome Measures :
  1. Postoperative Analgesia [ Time Frame: within 15 minutes at postanesthesia care unit (PACU) arrival ]
    Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain).

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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who scheduled to undergo upper extremity surgery requiring USSB for postoperative analgesia with ropivacaine alone or ropivacaine and adjuvants.

Inclusion Criteria:

  • Men and women 18-80 years old
  • Undergoing upper extremity surgery
  • Receiving Supraclavicular block
  • Receiving ropivacaine, ropivacaine adjuvants (dexamethasone, clonidine) for the supraclavicular nerve block.
  • Able to give Informed consent

Exclusion Criteria:

  • Age less than 18 and greater than 80 years
  • Inability to understand the study procedures
  • Significant respiratory dysfunction
  • Preexisting neurologic deficits
  • Allergy to local anesthetics
  • A bleeding diathesis or on anticoagulants
  • Systemic glucocorticoid use
  • Refuse to participate in the study

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 identifier (NCT number): NCT02151487

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United States, Texas
Parkland Health Hospital System
Dallas, Texas, United States, 750390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Dawood Nasir, MD University of Texas Southwestern Medical Center
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Responsible Party: Dawood Nasir, Associate Professor, University of Texas Southwestern Medical Center Identifier: NCT02151487    
Other Study ID Numbers: 102013-068
First Posted: May 30, 2014    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dawood Nasir, University of Texas Southwestern Medical Center:
Supraclavicular block
Postoperative analgesia
Additional relevant MeSH terms:
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Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents