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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

Tracking Information
First Submitted Date  ICMJE May 28, 2014
First Posted Date  ICMJE May 30, 2014
Last Update Posted Date September 5, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
Duration of the supraclavicular block [ Time Frame: 24-hr ]
Onset of the block to at the time of analgesic requirement
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
Duration of the supraclavicular block [ Time Frame: 24-h ]
Onset of the block to at the time of analgesic requirement
Change History Complete list of historical versions of study NCT02151487 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2014)
Postoperative analgesia [ Time Frame: 24-hr ]
Post-operative pain score
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2014)
Postoperative analgesia [ Time Frame: 24-h ]
Post-operative pain score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Upper Extremity Fracture
Intervention  ICMJE
  • 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
  • Drug: Ropivacaine, clonidine
    Ropivacaine together with clonidine
    Other Name: Noropin and adjuvant
Study Arms  ICMJE
  • Sham Comparator: Ropivacaine
    Ropivacaine 0.5% 25 ml alone for supraclavicular block
    Interventions:
    • Drug: Ropivacaine, dexamethasone
    • Drug: Ropivacaine, dexamethasone, clonidine
    • Drug: Ropivacaine, clonidine
  • Active Comparator: Ropivacaine, dexamethasone
    25 ml 0.5% ropivacaine + 4 mg dexamethasone
    Interventions:
    • Drug: Ropivacaine
    • Drug: Ropivacaine, dexamethasone, clonidine
    • Drug: Ropivacaine, clonidine
  • Active Comparator: Ropivacaine, clonidine
    25 ml 0.5% ropivacaine + 100 mcg clonidine
    Interventions:
    • Drug: Ropivacaine
    • Drug: Ropivacaine, dexamethasone
    • Drug: Ropivacaine, dexamethasone, clonidine
  • Active Comparator: Ropivacaine, dexamethasone, clonidine
    25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine
    Interventions:
    • Drug: Ropivacaine
    • Drug: Ropivacaine, dexamethasone
    • Drug: Ropivacaine, clonidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2016)
120
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2014)
200
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02151487
Other Study ID Numbers  ICMJE 102013-068
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dawood Nasir, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP