Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block
- Registration Number
- NCT05389852
- Lead Sponsor
- Hôpital du Valais
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are ASA physical status I-III
Exclusion criteria
- Patient refusal
- ASA physical status IV
- History of hypersensitivity or intolerance to dexmedetomidine
- History of hypersensitivity or intolerance to dexamethasone
- History of hypersensitivity or intolerance to local anesthetics
- History of recent (< 1 year) cerebrovascular insult
- Second or third degree heart block
- Uncontrolled hypotension
- Conditions contraindicating supraclavicular brachial plexus block: neurological deficit or neuropathy of the arm, severe hepatic dysfunction (Child B and C), coagulopathy, malignancy or infection in the area above the clavicle
- Chronic opioid use
- Pregnancy
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intravenous dexmedetomidine Dexmedetomidine Patients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed Placebo Dexmedetomidine Patients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed
- Primary Outcome Measures
Name Time Method duration of analgesia 24 hours on day of surgery time in minutes from end of injection of local anesthetic till first analgesic request
- Secondary Outcome Measures
Name Time Method Duration of motor block 24 hours on day of surgery time in minutes from completion of locoregional anesthesia and the moment the patient can again mobilize the arm
Duration of sensory block 24 hours on day of surgery time in minutes from completion of locoregional anesthesia and the moment the patient regains sensation of the arm
Pain scores at rest 4, 24, 48 hours postoperatively Pain scores at rest on numeric scale, 0=no pain at all to 10=worst pain imaginable
Pain scores on movement 4, 24, 48 hours postoperatively Pain scores on movement, on numeric scale, 0=no pain at all to 10=worst pain imaginable
Cumulative amount of opiate analgesic medication consumed 24, 48 hours postoperatively in intravenous morphine equivalents (mg)
Patient satisfaction 7 days postoperatively on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied
Total number of dexmedetomidine-related side effects 24 hours postoperatively Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension
Dexmedetomidine-related side effects 24 hours postoperatively Number and % of patients who experience at least one dexmedetomidine-related side effect
Opioid-related side effect 24 hours postoperatively Number and % of patients who experience at least one opioid-related side effect
Trial Locations
- Locations (1)
Hopital du Valais
🇨🇭Sion, Switzerland