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Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block

Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block: a Randomized Double-blinded Placebo Controlled Clinical Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05389852
Acronym
TwoDex
Enrollment
100
Registered
2022-05-25
Start date
2023-01-01
Completion date
2024-02-07
Last updated
2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

locoregional anesthesia, postoperative analgesia, hand surgery, dexmedetomidine

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.

Interventions

DRUGDexmedetomidine

After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg

Sponsors

Hôpital du Valais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

dexmedetomidine or placebo prepared by Lausanne University Hospital Pharmacy

Intervention model description

Patients undergoing forearm or hand surgery under supraclavicular brachial plexus block, receiving either additional intravenous dexmedetomidine or placebo

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
duration of analgesia24 hours on day of surgerytime in minutes from end of injection of local anesthetic till first analgesic request

Secondary

MeasureTime frameDescription
Duration of sensory block24 hours on day of surgerytime in minutes from completion of locoregional anesthesia and the moment the patient regains sensation of the arm
Pain scores at rest4, 24, 48 hours postoperativelyPain scores at rest on numeric scale, 0=no pain at all to 10=worst pain imaginable
Pain scores on movement4, 24, 48 hours postoperativelyPain scores on movement, on numeric scale, 0=no pain at all to 10=worst pain imaginable
Cumulative amount of opiate analgesic medication consumed24, 48 hours postoperativelyin intravenous morphine equivalents (mg)
Duration of motor block24 hours on day of surgerytime in minutes from completion of locoregional anesthesia and the moment the patient can again mobilize the arm
Total number of dexmedetomidine-related side effects24 hours postoperativelyTotal number of dexmedetomidine-related side effects, in particular bradycardia and hypotension
Dexmedetomidine-related side effects24 hours postoperativelyNumber and % of patients who experience at least one dexmedetomidine-related side effect
Opioid-related side effect24 hours postoperativelyNumber and % of patients who experience at least one opioid-related side effect
Patient satisfaction7 days postoperativelyon 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026