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Completed

NCT Number: NCT05389852

Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block

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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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital du Valais

Sion, 1950, Switzerland

About this study

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.

Who can participate

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

  • 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

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Dexdor

Primary outcomes

  1. duration of analgesia

    Time frame: 24 hours on day of surgery

    time in minutes from end of injection of local anesthetic till first analgesic request

Secondary outcomes

  1. Duration of motor block

    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

  2. Duration of sensory block

    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

  3. Pain scores at rest

    Time frame: 4, 24, 48 hours postoperatively

    Pain scores at rest on numeric scale, 0=no pain at all to 10=worst pain imaginable

  4. Pain scores on movement

    Time frame: 4, 24, 48 hours postoperatively

    Pain scores on movement, on numeric scale, 0=no pain at all to 10=worst pain imaginable

  5. Cumulative amount of opiate analgesic medication consumed

    Time frame: 24, 48 hours postoperatively

    in intravenous morphine equivalents (mg)

  6. Patient satisfaction

    Time frame: 7 days postoperatively

    on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied

  7. Total number of dexmedetomidine-related side effects

    Time frame: 24 hours postoperatively

    Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension

  8. Dexmedetomidine-related side effects

    Time frame: 24 hours postoperatively

    Number and % of patients who experience at least one dexmedetomidine-related side effect

  9. Opioid-related side effect

    Time frame: 24 hours postoperatively

    Number and % of patients who experience at least one opioid-related side effect

Sponsors and collaborators

Lead sponsor

Hôpital du Valais

Other

Registry information

Official study title

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

Acronym: TwoDex

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 25, 2022
Registry last updated
Feb 8, 2024

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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