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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Ropivacaine 0.5% 25 ml alone for supraclavicular block |
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| Ropivacaine and dexamethasone | 25 ml 0.5% ropivacaine + 4 mg dexamethasone |
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| Ropivacaine and clonidine | 25 ml 0.5% ropivacaine + 100 mcg clonidine |
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| Ropivacaine, dexamethasone and clonidine | 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Ropivacaine alone |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of the Sensorial Supraclavicular Block | 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 | within 24-hr after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Analgesia | Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain). | within 15 minutes at postanesthesia care unit (PACU) arrival |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who scheduled to undergo upper extremity surgery requiring USSB for postoperative analgesia with ropivacaine alone or ropivacaine and adjuvants.
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| Name | Affiliation | Role |
|---|---|---|
| Dawood Nasir, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health Hospital System | Dallas | Texas | 750390 | United States |
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Study takes place in routine clinical context. Subjects who received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants enrolled to the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine | Ropivacaine 0.5% 25 ml alone for supraclavicular block Ropivacaine: Ropivacaine alone |
| FG001 | Ropivacaine and Dexamethasone | 25 ml 0.5% ropivacaine + 4 mg dexamethasone Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ropivacaine and dexamethasone | Drug | Ropivacaine combination with dexamethasone |
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| Ropivacaine and clonidine | Drug | Ropivacaine combination with clonidine |
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| Ropivacaine, dexamethasone and clonidine | Drug | Ropivacaine combination with dexamethasone and clonidine |
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| FG002 | Ropivacaine and Clonidine | 25 ml 0.5% ropivacaine + 100 mcg clonidine Ropivacaine and clonidine: Ropivacaine combination with clonidine |
| FG003 | Ropivacaine, Dexamethasone and Clonidine | 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine | Ropivacaine 0.5% 25 ml alone for supraclavicular block Ropivacaine: Ropivacaine alone |
| BG001 | Ropivacaine and Dexamethasone | 25 ml 0.5% ropivacaine + 4 mg dexamethasone Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone |
| BG002 | Ropivacaine and Clonidine | 25 ml 0.5% ropivacaine + 100 mcg clonidine Ropivacaine and clonidine: Ropivacaine combination with clonidine |
| BG003 | Ropivacaine, Dexamethasone and Clonidine | 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants were ambulatory cases and followed with 24 h phone call visit. Due to follow-up lost, analysis population is lower than overall population. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of the Sensorial Supraclavicular Block | 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 | Participants received supraclavicular nerve block with ropivacaine alone and ropivacaine with adjuvants. | Posted | Mean | Standard Deviation | hour | within 24-hr after surgery |
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| Secondary | Postoperative Analgesia | Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain). | Patients received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants. Postoperative pain was evaluated by using Visual Analog Pain Scores on the scale of 10 (0=no pain and 10-worse pain). | Posted | Median | Inter-Quartile Range | score on a scale of 10 | within 15 minutes at postanesthesia care unit (PACU) arrival |
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Following nerve block to postoperative 24 hour period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ropivacaine | Ropivacaine 0.5% 25 ml alone for supraclavicular block Ropivacaine: Ropivacaine alone | 0 | 27 | 0 | 27 | 0 | 27 |
| EG001 | Ropivacaine and Dexamethasone | 25 ml 0.5% ropivacaine + 4 mg dexamethasone Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone | 0 | 27 | 0 | 27 | 1 | 27 |
| EG002 | Ropivacaine and Clonidine | 25 ml 0.5% ropivacaine + 100 mcg clonidine Ropivacaine and clonidine: Ropivacaine combination with clonidine | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Ropivacaine, Dexamethasone and Clonidine | 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine | 0 | 23 | 0 | 23 | 0 | 23 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of breath (SOB) | Respiratory, thoracic and mediastinal disorders | Shorness of breath | Systematic Assessment | Shortness of breath immediately after nerve block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawood Nasir | UT Southwestern Medical Center | 214-590-5352 | Dawood.Nasir@UTSouthwestern.edu |
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D003907 | Dexamethasone |
| D000277 | Adjuvants, Pharmaceutic |
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine
Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine
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