Clinical trial NCT05389852: Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block
Official title: Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block: a Randomized Double-blinded Placebo Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Surgery
Keywords: locoregional anesthesia
postoperative analgesia
hand surgery
dexmedetomidine
Lead sponsor: Hôpital du Valais
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergoing forearm or hand surgery under supraclavicular brachial plexus block, receiving either additional intravenous dexmedetomidine or placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: duration of analgesia
timeFrame: 24 hours on day of surgery
Secondary outcomes:
measure: Duration of motor block
timeFrame: 24 hours on day of surgery
measure: Duration of sensory block
timeFrame: 24 hours on day of surgery
measure: Pain scores at rest
timeFrame: 4, 24, 48 hours postoperatively
measure: Pain scores on movement
timeFrame: 4, 24, 48 hours postoperatively
measure: Cumulative amount of opiate analgesic medication consumed
timeFrame: 24, 48 hours postoperatively
measure: Patient satisfaction
timeFrame: 7 days postoperatively
measure: Total number of dexmedetomidine-related side effects
timeFrame: 24 hours postoperatively
measure: Dexmedetomidine-related side effects
timeFrame: 24 hours postoperatively
measure: Opioid-related side effect
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Hopital du Valais
Study officials:
affiliation: Valais Hospital
name: Sina Grape, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: