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
|Condition or disease||Intervention/treatment|
|Upper Extremity Surgery||Drug: Ropivacaine Drug: Ropivacaine and dexamethasone Drug: Ropivacaine and clonidine Drug: Ropivacaine, dexamethasone and clonidine|
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|
|Actual Enrollment :||97 participants|
|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|
Ropivacaine 0.5% 25 ml alone for supraclavicular block
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
- 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
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02151487
|United States, Texas|
|Parkland Health Hospital System|
|Dallas, Texas, United States, 750390|
|Principal Investigator:||Dawood Nasir, MD||University of Texas Southwestern Medical Center|