SurgeryPhase 4TwoDexNCT05389852
Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block
A Phase 4 study testing Dexmedetomidine in people with Surgery, run by Hôpital du Valais at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Surgery
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2023to 7 Feb 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are ASA physical status I-III
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block: a Randomized Double-blinded Placebo Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Surgery
- Being tested
- Dexmedetomidine
- Keywords
- locoregional anesthesia, postoperative analgesia, hand surgery, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| intravenous dexmedetomidine | Active comparator | Patients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Patients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of analgesia
time in minutes from end of injection of local anesthetic till first analgesic request
Measured: 24 hours on day of surgery
Secondary outcomes (9)
Duration of motor block
time in minutes from completion of locoregional anesthesia and the moment the patient can again mobilize the arm
Measured: 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
Measured: 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
Measured: 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
Measured: 4, 24, 48 hours postoperatively
Cumulative amount of opiate analgesic medication consumed
in intravenous morphine equivalents (mg)
Measured: 24, 48 hours postoperatively
Patient satisfaction
on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied
Measured: 7 days postoperatively
Total number of dexmedetomidine-related side effects
Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension
Measured: 24 hours postoperatively
Dexmedetomidine-related side effects
Number and % of patients who experience at least one dexmedetomidine-related side effect
Measured: 24 hours postoperatively
Opioid-related side effect
Number and % of patients who experience at least one opioid-related side effect
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jan 2023
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing forearm or hand surgery under supraclavicular brachial plexus block, receiving either additional intravenous dexmedetomidine or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sina Grape, MD, MBA, Principal investigator, Valais Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389852
- Sponsor's protocol ID
- Hopitalduvalais
- Acronym
- TwoDex
- Status last verified
- Mar 2023
- First submitted
- 12 May 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grape S, Andany A, Cibotto C, Berri L, Rossel JB, Albrecht E. Duration of analgesia after supraclavicular brachial plexus block with intravenous dexamethasone with or without dexmedetomidine: a randomised, placebo-controlled, triple-blind trial. Br J Anaesth. 2026 May;136(5):1588-1594. doi: 10.1016/j.bja.2025.10.049. Epub 2025 Dec 1.
PubMed 41330797
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block: a Randomized Double-blinded Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05389852
- Acronym / sponsor ID
- TwoDex / Hopitalduvalais
- Conditions
- Surgery
- Keywords
- locoregional anesthesia, postoperative analgesia, hand surgery, dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 7 Feb 2024 (actual)
- Study completion
- 7 Feb 2024 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients undergoing forearm or hand surgery under supraclavicular brachial plexus block, receiving either additional intravenous dexmedetomidine or placebo
| Arm | Type | Receives |
|---|---|---|
| intravenous dexmedetomidine | Active comparator | Drug: DexmedetomidinePatients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed |
| Placebo | Placebo comparator | Drug: DexmedetomidinePatients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are ASA physical status I-III
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: DexdorAfter completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg | Drug | Placebo, intravenous dexmedetomidine |
Primary outcome
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
9 secondary outcomes
Duration of motor block
Time frame: 24 hours on day of surgery
Duration of sensory block
Time frame: 24 hours on day of surgery
Pain scores at rest
Time frame: 4, 24, 48 hours postoperatively
Pain scores on movement
Time frame: 4, 24, 48 hours postoperatively
Cumulative amount of opiate analgesic medication consumed
Time frame: 24, 48 hours postoperatively
Patient satisfaction
Time frame: 7 days postoperatively
Total number of dexmedetomidine-related side effects
Time frame: 24 hours postoperatively
Dexmedetomidine-related side effects
Time frame: 24 hours postoperatively
Opioid-related side effect
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 41330797Grape S, Andany A, Cibotto C, Berri L, Rossel JB, Albrecht E. Duration of analgesia after supraclavicular brachial plexus block with intravenous dexamethasone with or without dexmedetomidine: a randomised, placebo-controlled, triple-blind trial. Br J Anaesth. 2026 May;136(5):1588-1594. doi: 10.1016/j.bja.2025.10.049. Epub 2025 Dec 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sina Grape, MD, MBA principal investigator
Valais Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Surgery, run by Hôpital du Valais at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of analgesia (time frame: 24 hours on day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.