Upper Extremity Surgery Clinical Trial
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
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Completed |
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Phase 4 | |
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