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

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ClinicalTrials.gov Identifier: NCT02151487
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
The aim of this randomized, observer-blinded clinical trial is to evaluate the anesthetic and 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 Phase
Upper Extremity Fracture Drug: Ropivacaine Drug: Ropivacaine, dexamethasone Drug: Ropivacaine, dexamethasone, clonidine Drug: Ropivacaine, clonidine Phase 3

Detailed Description:

Approximately, 50 patients in each groups undergoing orthopedic surgery of upper extremities will be 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.

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

The following clinical outcome will be assessed for up to 24 hr: Duration of the block, onset of the block, nausea, the number of vomiting, and complications of peripheral nerve block and used medications will be recorded. Pain at rest and movement will be 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 6 hr. after the block and postoperatively immediately at PACU, 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 (via pinprick test) will be assessed. Patient will be instructed to document at what time did hand motion (finger movement) return and what time normal sensation (hot/cold) return. Specific time for both events will be asked to patient at phone call visit 24 hr later. Overall patient satisfaction will be 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 will be 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Clinical Trial to Assess the Duration of Block
Study Start Date : March 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Sham Comparator: Ropivacaine
Ropivacaine 0.5% 25 ml alone for supraclavicular block
Drug: Ropivacaine, dexamethasone
Ropivacaine combination with dexamethasone
Other Name: Noropin and adjuvant

Drug: Ropivacaine, dexamethasone, clonidine
Ropivacaine combination with dexamethasone and clonidine
Other Name: Noropin and adjuvants

Drug: Ropivacaine, clonidine
Ropivacaine together with clonidine
Other Name: Noropin and adjuvant

Active Comparator: Ropivacaine, dexamethasone
25 ml 0.5% ropivacaine + 4 mg dexamethasone
Drug: Ropivacaine
Ropivacaine alone
Other Name: Noropin

Drug: Ropivacaine, dexamethasone, clonidine
Ropivacaine combination with dexamethasone and clonidine
Other Name: Noropin and adjuvants

Drug: Ropivacaine, clonidine
Ropivacaine together with clonidine
Other Name: Noropin and adjuvant

Active Comparator: Ropivacaine, clonidine
25 ml 0.5% ropivacaine + 100 mcg clonidine
Drug: Ropivacaine
Ropivacaine alone
Other Name: Noropin

Drug: Ropivacaine, dexamethasone
Ropivacaine combination with dexamethasone
Other Name: Noropin and adjuvant

Drug: Ropivacaine, dexamethasone, clonidine
Ropivacaine combination with dexamethasone and clonidine
Other Name: Noropin and adjuvants

Active Comparator: Ropivacaine, dexamethasone, clonidine
25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine
Drug: Ropivacaine
Ropivacaine alone
Other Name: Noropin

Drug: Ropivacaine, dexamethasone
Ropivacaine combination with dexamethasone
Other Name: Noropin and adjuvant

Drug: Ropivacaine, clonidine
Ropivacaine together with clonidine
Other Name: Noropin and adjuvant




Primary Outcome Measures :
  1. Duration of the supraclavicular block [ Time Frame: 24-hr ]
    Onset of the block to at the time of analgesic requirement


Secondary Outcome Measures :
  1. Postoperative analgesia [ Time Frame: 24-hr ]
    Post-operative pain score



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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
Criteria

Inclusion Criteria:

  • Men and women 18-80 years old
  • Undergoing upper extremity surgery
  • Receiving Supraclavicular 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 ClinicalTrials.gov identifier (NCT number): NCT02151487


Locations
United States, Texas
Parkland Health Hospital System
Dallas, Texas, United States, 750390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Dawood Nasir, MD University of Texas Southwestern Medical Center

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02151487     History of Changes
Other Study ID Numbers: 102013-068
First Posted: May 30, 2014    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University of Texas Southwestern Medical Center:
Supraclavicular block
Ropivacaine
Dexamethasone
Clonidine

Additional relevant MeSH terms:
Clonidine
Dexamethasone acetate
Dexamethasone
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
Analgesics
Antihypertensive Agents
Sympatholytics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents