Hopital du Valais
Sion, 1950, Switzerland
NCT Number: NCT05389852
The goal of the study is to compare the duration of analgesia in patients undergoing forearm or hand surgery with a supraclavicular brachial plexus block, who receive either iv dexmedetomidine or placebo.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Sion, 1950, Switzerland
Most surgical interventions on the forearm and the hand in Valais Hospital are performed under regional anesthesia. This ensures intraoperative patient comfort and reduces pain during the first 6 to 12 postoperative hours. A very common strategy to provide anesthesia of the arm is to inject local anesthetics in the region over the clavicle around the brachial plexus. This "supraclavicular brachial plexus block" is routinely performed in Valais Hospital and is always done under ultrasound guidance.
A drawback of locoregional anesthesia is the recurrence of pain once the effect of the block wears off after approximately 6 to 8 hours. This phenomenon is called rebound pain. It and can be very severe and debilitating, can significantly impact postoperative recovery and may also preclude ambulatory surgery as well as early mobilization and physiotherapy. Therefore, strategies that prolong the analgesic effect of locoregional anesthesia are warranted.
Dexmedetomidine is a selective α2-adrenoceptor agonists with sedative and analgesic properties. It has been shown to prolong the analgesic duration of local anesthetics when administered intravenously. However, the association of dexmedetomidine with long-acting local anesthetics for supraclavicular brachial plexus block has not been systematically investigated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are ASA physical status I-III
Exclusion criteria
After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg
Other names: Dexdor
Time frame: 24 hours on day of surgery
time in minutes from end of injection of local anesthetic till first analgesic request
Time frame: 24 hours on day of surgery
time in minutes from completion of locoregional anesthesia and the moment the patient can again mobilize the arm
Time frame: 24 hours on day of surgery
time in minutes from completion of locoregional anesthesia and the moment the patient regains sensation of the arm
Time frame: 4, 24, 48 hours postoperatively
Pain scores at rest on numeric scale, 0=no pain at all to 10=worst pain imaginable
Time frame: 4, 24, 48 hours postoperatively
Pain scores on movement, on numeric scale, 0=no pain at all to 10=worst pain imaginable
Time frame: 24, 48 hours postoperatively
in intravenous morphine equivalents (mg)
Time frame: 7 days postoperatively
on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied
Time frame: 24 hours postoperatively
Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension
Time frame: 24 hours postoperatively
Number and % of patients who experience at least one dexmedetomidine-related side effect
Time frame: 24 hours postoperatively
Number and % of patients who experience at least one opioid-related side effect
Hôpital du Valais
Other
Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block: a Randomized Double-blinded Placebo Controlled Clinical Trial
Acronym: TwoDex
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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