A Phase 4 interventional study of Dexmedetomidine in Surgery, sponsored by Hôpital du Valais. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-02-08.
Sponsored by Hôpital du Valais · Phase 4, Interventional, and Treatment
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.
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.
Hôpital du Valais is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are I-III
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed
Drug: Dexmedetomidine
Patients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed
Drug: Dexmedetomidine
After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg
Also known as: Dexdor
duration of analgesia
time in minutes from end of injection of local anesthetic till first analgesic request
Time frame: 24 hours on day of surgery
Duration of motor block
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
Duration of sensory block
time in minutes from completion of locoregional anesthesia and the moment the patient regains sensation of the arm
Time frame: 24 hours on day of surgery
Pain scores at rest
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
Pain scores on movement, on numeric scale, 0=no pain at all to 10=worst pain imaginable
Time frame: 4, 24, 48 hours postoperatively
Cumulative amount of opiate analgesic medication consumed
in intravenous morphine equivalents (mg)
Time frame: 24, 48 hours postoperatively
Patient satisfaction
on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied
Time frame: 7 days postoperatively
Total number of dexmedetomidine-related side effects
Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension
Time frame: 24 hours postoperatively
Dexmedetomidine-related side effects
Number and % of patients who experience at least one dexmedetomidine-related side effect
Time frame: 24 hours postoperatively
Opioid-related side effect
Number and % of patients who experience at least one opioid-related side effect
Time frame: 24 hours postoperatively
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Feb 2024, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dexmedetomidine
Hôpital du Valais