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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
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Dawood Nasir, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date May 28, 2014
First Posted Date May 30, 2014
Results First Submitted Date April 20, 2018
Results First Posted Date July 3, 2019
Last Update Posted Date July 3, 2019
Actual Study Start Date March 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2019)
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
Original Primary Outcome Measures
 (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
 (submitted: April 15, 2019)
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).
Original Secondary Outcome Measures
 (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 A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block
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
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.
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Upper Extremity Surgery
Intervention
  • Drug: Ropivacaine
    Ropivacaine alone
    Other Name: Noropin
  • Drug: Ropivacaine and dexamethasone
    Ropivacaine combination with dexamethasone
    Other Name: Noropin and adjuvant
  • Drug: Ropivacaine and clonidine
    Ropivacaine combination with clonidine
    Other Name: Noropin and adjuvants
  • Drug: Ropivacaine, dexamethasone and clonidine
    Ropivacaine combination with dexamethasone and clonidine
    Other Name: Noropin and adjuvants
Study Groups/Cohorts
  • Ropivacaine
    Ropivacaine 0.5% 25 ml alone for supraclavicular block
    Intervention: Drug: Ropivacaine
  • Ropivacaine and dexamethasone
    25 ml 0.5% ropivacaine + 4 mg dexamethasone
    Intervention: Drug: Ropivacaine and dexamethasone
  • Ropivacaine and clonidine
    25 ml 0.5% ropivacaine + 100 mcg clonidine
    Intervention: Drug: Ropivacaine and clonidine
  • Ropivacaine, dexamethasone and clonidine
    25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine
    Intervention: Drug: Ropivacaine, dexamethasone and 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 Completed
Actual Enrollment
 (submitted: April 15, 2019)
97
Original Estimated Enrollment
 (submitted: May 29, 2014)
200
Actual Study Completion Date August 20, 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02151487
Other Study ID Numbers 102013-068
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dawood Nasir, University of Texas Southwestern Medical Center
Study Sponsor University of Texas Southwestern Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Dawood Nasir, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date April 2019